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Applicable","secondaryObjectiveTranslations":[{"id":10771204,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"no procede","language":7,"languageDescription":"Spanish"},{"id":10771209,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"Nevzťahuje sa","language":22,"languageDescription":"Slovak"},{"id":10771206,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"Não aplicável","language":20,"languageDescription":"Portuguese"},{"id":10771208,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"Nem alkalmazandó","language":13,"languageDescription":"Hungarian"},{"id":10771207,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"Non applicable","language":34,"languageDescription":"French (France)"},{"id":10771205,"uuid":"dc485b3a-e1bb-42ce-a216-bd1e5a64d00d","attributeTranslation":"Неприложимо","language":1,"languageDescription":"Bulgarian"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":875144,"number":1,"principalInclusionCriteria":"Signed informed consent before any protocol-specific assessment is performed","principalInclusionCriteriaTranslations":[{"id":10771121,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Consentimiento informado firmado antes de que se realice cualquier evaluación específica del protocolo.","language":7,"languageDescription":"Spanish"},{"id":10771124,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Podpísaný informovaný súhlas pred vykonaním akéhokoľvek hodnotenia špecifického pre protokol","language":22,"languageDescription":"Slovak"},{"id":10771123,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Подписано информирано съгласие преди извършване на каквато и да е специфична за протокола оценка","language":1,"languageDescription":"Bulgarian"},{"id":10771122,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Avoir signé le consentement éclairé avant toute évaluation spécifique au protocole","language":34,"languageDescription":"French (France)"},{"id":10771120,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Aláírt tájékoztatás utáni beleegyező nyilatkozat bármilyen protokoll-specifikus értékelés elvégzése előtt","language":13,"languageDescription":"Hungarian"},{"id":10771119,"uuid":"8d2c7663-5524-46d1-9b29-d2ce62a0439a","attributeTranslation":"1. Consentimento informado assinado antes de ser realizada qualquer avaliação específica do protocolo","language":20,"languageDescription":"Portuguese"}]},{"id":875145,"number":10,"principalInclusionCriteria":"BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit","principalInclusionCriteriaTranslations":[{"id":10771129,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. MAVC entre 25 et 78 lettres de l’ETDRS incluses (20/320-20/32 équivalent Snellen) dans l’œil étudié lors de la visite de sélection","language":34,"languageDescription":"French (France)"},{"id":10771125,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. MAVC entre 25 e 78 letras ETDRS, inclusive (20/320-20/32 equivalente de Snellen) no olho do estudo na Consulta de Seleção","language":20,"languageDescription":"Portuguese"},{"id":10771126,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. 25 és 78 ETDRS betű közötti BCVA (20/320-20/32 Snellen-egyenérték) a vizsgált szemen a szűrő viziten","language":13,"languageDescription":"Hungarian"},{"id":10771127,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. MAVC de entre 25 y 78 letras del ETDRS, incluso (equivalente a 20/320-20/32 en la prueba de Snellen) en el ojo del estudio en la visita de selección.","language":7,"languageDescription":"Spanish"},{"id":10771128,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. BCVA между 25 и 78 ETDRS букви, включително (20/320-20/32 еквивалент на Snellen) в изследваното око на визитата за скрининг","language":1,"languageDescription":"Bulgarian"},{"id":10771130,"uuid":"4e0b33df-c08e-4bdf-8f48-de097f9d321f","attributeTranslation":"10. BCVA v rozmedzí 25 a 78 písmen ETDRS (vrátane) (čomu zodpovedá Snellenov optotyp 20/320-20/32) v skúšanom oku pri skríningovej návšteve","language":22,"languageDescription":"Slovak"}]},{"id":875146,"number":11,"principalInclusionCriteria":"BCVA ≥34 ETDRS letters (~20/200 Snellen equivalent) in the contralateral eye at the Screening Visit","principalInclusionCriteriaTranslations":[{"id":10771136,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. BCVA ≥ 34 písmen ETDRS (čomu približne zodpovedá Snellenov optotyp 20/200) v kontralaterálnom oku pri skríningovej návšteve","language":22,"languageDescription":"Slovak"},{"id":10771134,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. BCVA ≥34 ETDRS betű (~20/200 Snellen ekvivalens) a kontralaterális szemben a szűrési viziten","language":13,"languageDescription":"Hungarian"},{"id":10771135,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. MAVC ≥ 34 lettres de l’ETDRS (~20/200 équivalent Snellen) dans l’œil controlatéral à la visite de sélection","language":34,"languageDescription":"French (France)"},{"id":10771132,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. MAVC de ≥34 letras del ETDRS (equivalente a ~20/200 en la prueba de Snellen) en el ojo contralateral en la visita de selección.","language":7,"languageDescription":"Spanish"},{"id":10771131,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. MAVC ≥34 letras ETDRS (equivalente a ~20/200 Snellen) no olho contralateral na Consulta de Seleção","language":20,"languageDescription":"Portuguese"},{"id":10771133,"uuid":"41177da7-1f61-49d2-9fc6-7e3cd5d0209f","attributeTranslation":"11. BCVA ≥34 ETDRS букви (~20/200 еквивалент на Snellen) в контралатералното око на визитата за скрининг","language":1,"languageDescription":"Bulgarian"}]},{"id":875147,"number":12,"principalInclusionCriteria":"Study eye amenable to IVT injection identified by the Investigator prior to Week −5","principalInclusionCriteriaTranslations":[{"id":10771141,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. Olho em estudo propício à injeção IVT identificada pelo investigador antes da Semana −5","language":20,"languageDescription":"Portuguese"},{"id":10771140,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. A vizsgáló által a -5. hét előtt azonosított, IVT injekcióra alkalmas vizsgált szem","language":13,"languageDescription":"Hungarian"},{"id":10771138,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. Œil étudié pouvant faire l’objet d’une injection IVT identifié par l’investigateur avant la Semaine 5","language":34,"languageDescription":"French (France)"},{"id":10771142,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. Skúšané oko možno liečiť IVT injekciou podľa zistenia skúšajúceho pred týždňom -5","language":22,"languageDescription":"Slovak"},{"id":10771137,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. Изследвано око, податливо на IVT инжекция, установено от изследователя преди седмица −5","language":1,"languageDescription":"Bulgarian"},{"id":10771139,"uuid":"777439dd-c16a-4266-bd4c-1a5d98c1538a","attributeTranslation":"12. Ojo del estudio susceptible de inyección IVT identificado por el investigador antes de la semana −5.","language":7,"languageDescription":"Spanish"}]},{"id":875148,"number":2,"principalInclusionCriteria":"Ability to comply with the protocol-specified procedures and visits, in the Investigator’s judgment","principalInclusionCriteriaTranslations":[{"id":10771146,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. Capacidad para cumplir con los procedimientos y visitas especificados en el protocolo, a juicio del investigador.","language":7,"languageDescription":"Spanish"},{"id":10771143,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. A vizsgáló megítélése szerint képes eleget tenni a protokoll által előírt eljárások és vizitek követelményeinek","language":13,"languageDescription":"Hungarian"},{"id":10771147,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. Capacidade para cumprir os procedimentos e consultas especificados no protocolo, de acordo com o parecer do Investigador","language":20,"languageDescription":"Portuguese"},{"id":10771145,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. Способност за спазване на определените по протокол процедури и визити, по преценка на изследователя","language":1,"languageDescription":"Bulgarian"},{"id":10771144,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. Être capable de se conformer aux procédures et aux visites prévues dans le cadre du protocole, selon le jugement de l’investigateur","language":34,"languageDescription":"French (France)"},{"id":10771148,"uuid":"917bb70a-fc8e-4c3d-a1b3-824840216040","attributeTranslation":"2. Schopnosť dodržiavať procedúry a návštevy špecifikované v protokole, podľa úsudku skúšajúceho","language":22,"languageDescription":"Slovak"}]},{"id":875149,"number":3,"principalInclusionCriteria":"≥50 years of age at time of consent","principalInclusionCriteriaTranslations":[{"id":10771152,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. ≥50 anos de idade na data do consentimento","language":20,"languageDescription":"Portuguese"},{"id":10771151,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. ≥50 años en el momento del consentimiento.","language":7,"languageDescription":"Spanish"},{"id":10771150,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. életkor, betöltött 50. év a beleegyezés időpontjában","language":13,"languageDescription":"Hungarian"},{"id":10771149,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. Avoir ≥50 ans au moment du consentement","language":34,"languageDescription":"French (France)"},{"id":10771154,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. Vek ≥ 50 rokov v čase udelenia súhlasu","language":22,"languageDescription":"Slovak"},{"id":10771153,"uuid":"ec0ba5f1-df84-4658-b648-65c9a64cea8e","attributeTranslation":"3. Възраст ≥50 години към момента на даване на съгласие","language":1,"languageDescription":"Bulgarian"}]},{"id":875150,"number":4,"principalInclusionCriteria":"Agree to use a barrier method (e.g. condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period.","principalInclusionCriteriaTranslations":[{"id":10771159,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Accepter d’utiliser une méthode barrière (p. ex. préservatif) lors des rapports sexuels pendant les 3 mois suivant le jour 1 pour prévenir la transmission de fluides ; Les hommes sexuellement actifs ne doivent pas avoir d’enfant ou faire don de leur sperme pendant cette période.","language":34,"languageDescription":"French (France)"},{"id":10771158,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Beleegyezik barrier módszer (pl. kondom) alkalmazásába az 1. napot követő 3 hónapon át tartó közösülései során a folyadékátvitel megakadályozása érdekében; a szexuálisan aktív férfiak nem nemzhetnek gyermeket, és nem adományozhatnak spermát ebben az időszakban.","language":13,"languageDescription":"Hungarian"},{"id":10771155,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Aceptar utilizar un método de barrera (p. ej., preservativo) al tener relaciones sexuales durante los 3 meses posteriores al día 1 para prevenir la transmisión de fluidos; los hombres sexualmente activos no deben engendrar un hijo ni donar esperma durante este periodo.","language":7,"languageDescription":"Spanish"},{"id":10771160,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Súhlas s používaním bariérovej metódy antikoncepcie (napr. kondómu) počas pohlavného styku v priebehu 3 mesiacov po 1. dni, aby sa zabránilo prenosu tekutín; sexuálne aktívni muži by počas tohto obdobia nemali splodiť dieťa ani darovať spermie.","language":22,"languageDescription":"Slovak"},{"id":10771156,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Съгласие да се използва бариерен метод (напр. презерватив) по време на полов акт в продължение на 3 месеца след Ден 1, за да се предотврати предаването на течности; сексуално активните мъже не трябва да зачеват дете или да даряват сперма през този период.","language":1,"languageDescription":"Bulgarian"},{"id":10771157,"uuid":"92b6bca4-b920-4a85-8fe2-88aca3b2c891","attributeTranslation":"4. Concordar em utilizar um método de barreira (por exemplo, preservativo) durante as relações sexuais durante 3 meses após o Dia 1 para evitar a transmissão de fluidos; os homens sexualmente ativos não devem ser pais de uma criança ou doar esperma durante este período.","language":20,"languageDescription":"Portuguese"}]},{"id":875151,"number":5,"principalInclusionCriteria":"MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:  a. Treatment naïve, i.e. no prior IVT anti-VEGF therapy, OR  b. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND   Documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator","principalInclusionCriteriaTranslations":[{"id":10771166,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. MNV ako sekundárny stav pri nAMD s predošlou IVT liečbou anti-VEGF v skúšanom oku, definovaný BUĎ ako: \na. neliečený stav, tzn. bez predošlej IVT liečby anti-VEGF, \n\nALEBO ako\nb. stav, ktorý bol v minulosti liečený najviac štyrmi (4) IVT injekciami anti-VEGF z dôvodu nAMD, pričom nAMD bola diagnostikovaná najviac 6 mesiacov pred skríningovou návštevou, A \n\nzdokumentovaný dôkaz anatomického zlepšenia a stability videnia/zlepšenia v reakcii na predchádzajúcu IVT liečbu anti-VEGF podľa určenia skúšajúceho","language":22,"languageDescription":"Slovak"},{"id":10771165,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. NVM secundaria a DMAEn con antecedentes de tratamiento antiVEGF IVT en el ojo del estudio, definida como UNA DE LAS SIGUIENTES CIRCUNSTANCIAS: \na. No haber recibido tratamiento previo con antiVEGF IVT, O \nb. Haber recibido tratamiento previamente con no más de 4 inyecciones antiVEGF IVT debido a DMAEn y un diagnóstico de DMAEn no más de 6 meses antes de la visita de selección Y \nTener indicios documentados de mejora anatómica y estabilidad/mejora visual en respuesta al tratamiento previo con antiVEGF IVT, según lo determine el investigador.","language":7,"languageDescription":"Spanish"},{"id":10771161,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. Présenter une néovascularisation maculaire (NVM) secondaire à la DMLAn avec antécédents de traitement anti-VEGF IVT dans l’œil à l’étude, défini comme\nSOIT :\na. Être naïf de traitement, c.à.d. sans aucune thérapie anti-VEGF IVT antérieure, OU\nb. Avoir été précédemment traité avec pas plus de 4 injections d’anti-VEGF IVT en raison de la DMLA et avoir reçu un diagnostic de DMLAn au plus tard 6 mois avant la visite de sélection ET \nAvoir une preuve documentée d’une amélioration anatomique et d’une stabilité/amélioration visuelle en réponse à un traitement anti-VEGF IVT antérieur, tel que déterminé par l’investigateur","language":34,"languageDescription":"French (France)"},{"id":10771164,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. MNV вследствие на nAMD с анамнеза за лечение с IVT анти-VEGF в изследваното око, дефинирана като ИЛИ: \nа. Нелекувани преди това, т.е. не са имали предишна терапия с IVT анти-VEGF, ИЛИ \nб. Лекувани преди това с не повече от 4 IVT инжекции с анти-VEGF поради nAMD и получили диагноза nAMD не повече от 6 месеца преди визитата за скрининг И \nДокументирани доказателства за анатомично подобрение и визуална стабилност/подобрение в отговор на предишно лечение с IVT анти-VEGF, според преценката на изследователя","language":1,"languageDescription":"Bulgarian"},{"id":10771163,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. MNV secundária a DMRI com historial de tratamento anti-VEGF IVT no olho do estudo, definida como OU:\na. Sem exposição anterior ao tratamento, ou seja, sem terapêutica anterior anti-VEGF IVT, OU \nb. Anteriormente tratado com não mais de 4 injeções IVT anti-VEGF devido a DMRI e recebeu o diagnóstico de DMRI não mais de 6 meses antes da Consulta de Seleção E \nEvidência documentada de melhoria anatómica e estabilidade/melhoria visual em resposta a tratamento anterior com anti-VEGF IVT, conforme determinado pelo Investigador","language":20,"languageDescription":"Portuguese"},{"id":10771162,"uuid":"74198336-a6ad-4dcd-be25-e1dd78a876b4","attributeTranslation":"5. Az nAMD miatt másodlagos MNV, IVT anti-VEGF kezelési előzményekkel a vizsgált szemben, a következő meghtározások EGYIKE szerint: \na. Korábban még nem kezelt, azaz korábban nem kapott IVT anti-VEGF terápiát, VAGY \nb. Korábban legfeljebb 4 alkalommal kezelték IVT anti-VEGF injekcióval nAMD miatt, és a szűrési vizit előtt nem korábban 6 hónapnál diagnosztizálták nAMD-vel, ÉS \nA vizsgáló megítélése szerint dokumentummal bizonyított az anatómiai javulás és a látás stabilitása/javulása a korábbi IVT anti-VEGF kezelésre adott válaszként","language":13,"languageDescription":"Hungarian"}]},{"id":875152,"number":6,"principalInclusionCriteria":"Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center","principalInclusionCriteriaTranslations":[{"id":10771168,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. Активна субфовеална MNV или MNV до фовеята/ извън фовеята със субфовеален компонент (когато активността се дефинира като доказателство за SRF, IRF, субретинален хиперрефлекторен материал или изтичане), идентифициран чрез флуоресцеинова ангиография (ФА) или оптична кохерентна томография на спектрален домейн (SD-OCT), в изследваното око, при визитата за скрининг, потвърден от Центъра за разчитане","language":1,"languageDescription":"Bulgarian"},{"id":10771171,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. Aktív szubfoveális MNV vagy juxtafoveális/exfoveális MNV egy szubfoveális komponenssel (ahol az aktivitás meghatározása: SRF, IRF, szubretinális hiperreflektív anyag vagy szivárgás) fluoreszcein angiográfiával (FA) vagy spektrális domén optikai koherencia tomográfiával (SD-OCT) kimutatva a vizsgált szemben, a szűrési viziten, amit az Olvasóközpont megerősít","language":13,"languageDescription":"Hungarian"},{"id":10771169,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. MNV subfoveal ativa ou MNV justafoveal/extrafoveal com um componente subfoveal (em que a atividade é definida como evidência de SRF, IRF, material hiper-reflexivo subretiniano ou fuga) identificada por angiografia de fluoresceína (FA) ou tomografia de coerência ótica de domínio espectral (SD-OCT), no olho do estudo, na Consulta de Estudo confirmada pelo Centro de Leitura","language":20,"languageDescription":"Portuguese"},{"id":10771170,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. NVM subfoveal activa o NVM yuxtafoveal/extrafoveal con un componente subfoveal (donde la actividad se define como indicios de FSR, FIR, material hiperreflectivo subretiniano o fuga) identificada mediante angiografía con fluoresceína (AF) o tomografía de coherencia óptica de dominio espectral (TCO-DE) en el ojo del estudio, en la visita de selección confirmada por el centro de lectura.","language":7,"languageDescription":"Spanish"},{"id":10771172,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. Aktívna subfoveálna MNV alebo juxtafoveálna/extrafoveálna MNV so subfoveálnou zložkou (pričom aktivita je definovaná ako dôkaz SRF, IRF, subretinálneho hyperreflexného materiálu alebo výtoku) identifikovaná fluoresceínovou angiografiou (FA) alebo optickou koherentnou tomografiou spektrálnej domény (SD-OCT) v skúšanom oku pri skríningovej návšteve, potvrdená interpretačným centrom","language":22,"languageDescription":"Slovak"},{"id":10771167,"uuid":"11e8082c-11cf-4d02-bfd9-f28ff50c6515","attributeTranslation":"6. MNV sous-fovéale active ou MNV juxtafovéale/extrafovéale avec une composante sous-fovéale (où l’activité est définie comme la preuve de SRF, de IRF, d’un matériau hyperréflectif sous-rétinien ou d’une fuite) identifié par angiographie à la fluorescéine (AF) ou tomographie par cohérence optique en domaine spectral (DS-TCO), dans l’œil étudié, lors de la visite de sélection confirmée par le centre de lecture.","language":34,"languageDescription":"French (France)"}]},{"id":875153,"number":7,"principalInclusionCriteria":"MNV lesion in the study eye of any type (i.e. predominantly classic, minimally classic, or occult [including polypoidal choroidal vasculopathy and retinal angiomatous proliferation]) at the Screening Visit, confirmed by the Reading Center, which exhibits all of the following characteristics:  a. Total lesion size of 9 disc areas or less (inclusive of blood, fibrosis, atrophy or neovascularization) on FA  b. MNV component area at least 50% of total lesion size on FA  c. MNV exudation (i.e. presence of fluid) on SD-OCT","principalInclusionCriteriaTranslations":[{"id":10771175,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. Lésion MNV dans l’œil étudié de tout type (c.-à-d. principalement classique, peu classique ou occulte [y compris la vasculopathie choroïdienne polypoïdale et la prolifération angiomateuse rétinienne]) à la visite de sélection, confirmée par le centre de lecture, présentant toutes les caractéristiques suivantes : \na. Taille totale de la lésion de 9 zones discales ou moins (y compris le sang, la fibrose, l’atrophie ou la néovascularisation) sous AF \nb. Surface de la composante NVM au moins 50 % de la taille totale de la lésion sous AF \nc. Exsudation des MNV (c.-à-d. présence de liquide) sur TCO-DS","language":34,"languageDescription":"French (France)"},{"id":10771177,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. Lesão de MNV no olho do estudo de qualquer tipo (ou seja, predominantemente clássica, minimamente clássica ou oculta [incluindo vasculopatia polipoidal coroidal e proliferação angiomatosa da retina]) na Consulta de Seleção, confirmada pelo Centro de Leitura, que exibe todas as seguintes características: \na. Tamanho total da lesão de 9 áreas discais ou menos (incluindo sangue, fibrose, atrofia ou neovascularização) na FA \nb. Área de componente MNV pelo menos 50% do tamanho total da lesão na FA \nc. Exsudação de MNV (ou seja, presença de fluido) no SD-OCT","language":20,"languageDescription":"Portuguese"},{"id":10771173,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. Lesión de NVM en el ojo del estudio de cualquier tipo (es decir, predominantemente clásica, mínimamente clásica u oculta [incluida la vasculopatía coroidea polipoidea y la proliferación angiomatosa retiniana]) en la visita de selección, confirmada por el centro de lectura, que muestre todas las características siguientes: \na. Tamaño total de la lesión de 9 áreas del disco o menos (incluida sangre, fibrosis, atrofia o neovascularización) en la AF. \nb. Área del componente de NVM de al menos 50 % del tamaño total de la lesión en la AF. \nc. Exudado de NVM (es decir, presencia de fluido) en la TCO-DE.","language":7,"languageDescription":"Spanish"},{"id":10771176,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. MNV lézió a vizsgált szemben a szűrési viziten, bármilyen típusú (pl. dominánsan klasszikus, kis mértékben klasszikus vagy rejtett [ideértve a polip alakú choroidalis vasculopathiát és a retina angiomatózus proliferációt]), amit az Olvasóközpont megerősít, és amely az alábbi jellemzők mindegyikét mutatja: \na. FA esetén a lézió teljes mérete legfeljebb 9 porckorongterület (beleértve vért, fibrózist, atrófiát és neovaszkularizációt) \nb. Az MNV komponens területe az FA-n a teljes lézióméret legalább 50%-a \nc. MNV exudáció (azaz folyadék jelenléte) az SD-OCT-n","language":13,"languageDescription":"Hungarian"},{"id":10771178,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. Lézia MNV v skúšanom oku akéhokoľvek typu (tzn. prevažne klasická, minimálne klasická alebo okultná [vrátane polypoidálnej choroidálnej vaskulopatie a angiomatóznej proliferácie sietnice]) pri skríningovej návšteve, ktorá je potvrdená interpretačným centrom a vykazuje všetky nasledujúce charakteristiky: \na. Celková veľkosť lézie 9 diskových oblastí alebo menej (vrátane krvi, fibrózy, atrofie alebo neovaskularizácie) pri FA \nb. Veľkosť plochy MNV zložky najmenej 50 % celkovej veľkosti lézie pri FA \nc. Exsudácia MNV (tzn. prítomnosť tekutiny) pri SD-OCT","language":22,"languageDescription":"Slovak"},{"id":10771174,"uuid":"60eec5c0-4be2-4431-8791-5020a05f8454","attributeTranslation":"7. Лезия на MNV в изследваното око от всякакъв вид (т.е. предимно класическа, минимално класическа или окултна [включително полипоидна хороидална васкулопатия и ретинална ангиоматозна пролиферация]) на визитата за скрининг, потвърдена от Центъра за разчитане, която показва всички от следните характеристики: \nа. Общ размер на лезията в 9 дискови зони или по-малко (включително кръв, фиброза, атрофия или неоваскуларизация) при FA \nб. Зона на MNV компонента най-малко 50% от общия размер на лезията при FA \nв. MNV ексудация (т.е. наличие на течност) на SD-OCT","language":1,"languageDescription":"Bulgarian"}]},{"id":875154,"number":8,"principalInclusionCriteria":"CST ≤500μm in the study eye at Screening visit, confirmed by the Reading Center","principalInclusionCriteriaTranslations":[{"id":10771181,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. CST ≤500 μm a vizsgált szemben a szűrési viziten, amit az Olvasóközpont megerősít","language":13,"languageDescription":"Hungarian"},{"id":10771182,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. CST ≤500μm в изследваното око на скрининговата визита, потвърдено от Центъра за разчитане","language":1,"languageDescription":"Bulgarian"},{"id":10771183,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. ESC ≤500 μm no olho do estudo na Consulta de Seleção, confirmado pelo Centro de Leitura","language":20,"languageDescription":"Portuguese"},{"id":10771184,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. CST ≤ 500 μm v skúšanom oku pri skríningovej návšteve, potvrdená interpretačným centrom","language":22,"languageDescription":"Slovak"},{"id":10771179,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. CST ≤ 500 μm dans l’œil étudié lors de la visite de sélection, confirmée par le centre de lecture","language":34,"languageDescription":"French (France)"},{"id":10771180,"uuid":"dc3cc5d7-b420-410a-a1f4-187b5ae97bfc","attributeTranslation":"8. GSC ≤500 μm en el ojo del estudio en la visita de selección, confirmado por el centro de lectura.","language":7,"languageDescription":"Spanish"}]},{"id":875155,"number":9,"principalInclusionCriteria":"Demonstrated clinical response to aflibercept and functional stability in the study eye:  a. From Week −5 to Week −1: a ≥ 15% reduction in CST or complete resolution of IRF and/or SRF, determined by SD-OCT and confirmed by the Reading Center  b. At Day 1: BCVA measurement must not have decreased by 15 ETDRS letters or more compared to BCVA at the Screening visit","principalInclusionCriteriaTranslations":[{"id":10771190,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Preukázaná klinická odpoveď na aflibercept a funkčná stabilita v skúšanom oku: \na. Od týždňa -5 do týždňa -1: ≥ 15 % zníženie CST alebo úplné vyliečenie IRF a/alebo SRF, určené pomocou SD-OCT a potvrdené interpretačným centrom \nb. V 1. deň: nameraná hodnota BCVA sa nesmie znížiť o 15 písmen ETDRS alebo viac v porovnaní s BCVA pri skríningovej návšteve.","language":22,"languageDescription":"Slovak"},{"id":10771188,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Respuesta clínica demostrada a aflibercept y estabilidad funcional en el ojo del estudio: \na. Desde la semana −5 hasta la semana −1: reducción del ≥15 % en el GSC o resolución completa del FIR o el FSR, determinado mediante TCO-DE y confirmado por el centro de lectura. \nb. En el día 1: la medición de la MAVC no debe haber disminuido en 15 letras del estudio para el tratamiento temprano de la retinopatía diabética (ETDRS) o más en comparación con la MAVC en la visita de selección.","language":7,"languageDescription":"Spanish"},{"id":10771185,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Réponse clinique démontrée à l’aflibercept et stabilité fonctionnelle dans l’œil étudié : \na. De la Semaine 5 à la Semaine 1 : réduction ≥ 15 % du TCS ou résolution complète du CRI et/ou du CRI, déterminée par TCO-DS et confirmée par le centre de lecture \nb. Au Jour 1 : La mesure de la MAVC ne doit pas avoir diminué de 15 lettres de l’ETDRS ou plus par rapport à la MAVC à la visite de sélection","language":34,"languageDescription":"French (France)"},{"id":10771186,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Демонстриран клиничен отговор към афлиберцепт и функционална стабилност в изследваното око: \nа. От седмица −5 до седмица −1: ≥ 15% намаление на CST или пълно преминаване на IRF и/или SRF, определено чрез SD-OCT и потвърдено от Центъра за разчитане \nб. В Ден 1: Измерването на BCVA не трябва да е намаляло с 15 ETDRS букви или повече в сравнение с BCVA на визитата за скрининг","language":1,"languageDescription":"Bulgarian"},{"id":10771187,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Bizonyított klinikai válasz az afliberceptre és funkcionális stabilitás a vizsgált szemben: \na. A −5. héttől a −1. hétig: a CST ≥15%-os csökkenése vagy az IRF és/vagy az SRF teljes rendeződése, az SD-OCT megállapítása szerint, és az Olvasóközpont által megerősítve \nb. Az 1. napon: A szűrési viziten BCVA mérés nem csökkenthet 15 ETDRS betűvel vagy nagyobb mértékben a BCVA-hoz képest","language":13,"languageDescription":"Hungarian"},{"id":10771189,"uuid":"f5eba1ae-6ad4-48a8-b682-0a66fd82c2d4","attributeTranslation":"9. Resposta clínica comprovada ao aflibercept e estabilidade funcional no olho do estudo: \na. Da semana −5 à semana −1: uma redução de ≥ 15% no CST ou resolução completa do IRF e/ou SRF, determinada pelo SD-OCT e confirmada pelo Centro de Leitura \nb. No Dia 1: A medição da MAVC não deve ter diminuído em 15 letras ETDRS ou mais comparativamente à MAVC na Consulta de Seleção","language":20,"languageDescription":"Portuguese"}]}],"principalExclusionCriteria":[{"id":1496480,"number":1,"principalExclusionCriteria":"Ocular Conditions:  a. MNV due to causes other than nAMD in either eye  b. Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter), retinal pigment epithelial tear, macular hole, vitreomacular traction, Stargardt disease, drug induced maculopathies, macular edema not due to nAMD, or retinal neovascular occlusion, in the study eye as determined by the Reading Center at the Screening Visit  c. History of retinal detachment in the study eye  d. Any active ocular inflammation or active ocular or periocular infection in either eye (e.g. infectious blepharoconjunctivitis) at any time between the Screening Visit and Randomization.  e. History of intraocular inflammation (e.g. endophthalmitis), or uveitis in either eye, or presence of any cells or flare in the anterior chamber or any cells or haze in the vitreous in the study eye at any time prior to Randomization.  f. History of latent ocular or periocular infection (e.g. ocular syphilis, herpetic eye disease) g. History of steroid-induced ocular hypertension or steroid-induced glaucoma in either eye h. Intraocular pressure (IOP) <6 mmHg (by Goldmann tonometry) in the study eye  i. Any history of ocular hypotony or ciliary body dysfunction/pathology in either eye as determined by the Investigator j. Glaucoma or intraocular hypertension requiring more than 2 topical medications for control (defined as IOP <22 mm Hg) in the study eye  k. Any other pre-existing eye conditions or surgical complications that in the opinion of the Investigator would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints.","principalExclusionCriteriaTranslations":[{"id":10771086,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Condições oculares: \na. MNV devido a causas que não a DMRI em ambos os olhos \nb. Fibrose, atrofia ou hemorragia sub-retiniana no subcampo central da fóvea (1 mm de diâmetro), rasgo do epitélio pigmentar da retina, buraco macular, tração vitreomacular, doença de Stargardt, maculopatias induzidas por fármacos, edema macular não devido a DMRI ou oclusão neovascular da retina, no olho do estudo, conforme determinado pelo Centro de Leitura na Consulta de Seleção \nc. História de descolamento da retina no olho do estudo \nd. Qualquer inflamação ocular ativa ou infeção ocular ou periocular ativa em qualquer um dos olhos (por exemplo, blefaroconjuntivite infeciosa) a qualquer momento entre a Consulta de Seleção e a Aleatorização. \ne. História de inflamação intraocular (por exemplo, endoftalmite) ou uveíte em qualquer um dos olhos, ou presença de quaisquer células ou flare na câmara anterior ou quaisquer células ou opacidade no vítreo no olho em estudo em qualquer momento antes da aleatorização. \nf. História de infeção ocular ou periocular latente (por exemplo, sífilis ocular, doença ocular herpética) \ng. Historial de hipertensão ocular induzida por esteroides ou glaucoma induzido por esteroides em qualquer um dos olhos \nh. Pressão intraocular (PIO) <6 mmHg (por tonometria de Goldmann) no olho do estudo \ni. Qualquer historial de hipotonia ocular ou disfunção/patologia do corpo ciliar em qualquer dos olhos, conforme determinado pelo Investigador.\nj. Glaucoma ou hipertensão intraocular que exija mais de 2 medicações tópicas para controlo (definido como PIO <22 mm Hg) no olho do estudo \nk. Quaisquer outras condições oculares pré-existentes ou complicações cirúrgicas que, na opinião do Investigador, impeçam a participação num ensaio clínico de intervenção ou interfiram com a interpretação dos parâmetros de avaliação do estudo.","language":20,"languageDescription":"Portuguese"},{"id":10771082,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Conditions oculaires : \na. MNV dû à des causes autres que la DMLAn dans un œil ou l’autre \nb. Fibrose, atrophie ou hémorragie sous-rétinienne dans le sous-champ central fovéal (diamètre de 1 mm), déchirure épithéliale pigmentaire rétinienne, trou maculaire, traction vitréo-maculaire, maladie de Stargardt, maculopathies médicamenteuses, œdème maculaire non dû à la DMLAn ou occlusion néovasculaire rétinienne, dans l’œil étudié, tel que déterminé par le centre de lecture lors de la visite de sélection \nc. Antécédents de décollement de la rétine dans l’œil étudié \nd. Toute inflammation oculaire active ou infection oculaire ou périoculaire active dans un œil ou l’autre (par ex., blépharoconjonctivite infectieuse) à tout moment entre la visite de sélection et la randomisation. \ne. Antécédents d’inflammation intraoculaire (par ex., endophtalmie) ou uvéite dans un œil ou l’autre, ou présence de cellules ou d’une poussée dans la chambre antérieure ou de cellules ou de trouble dans le vitré de l’œil étudié à tout moment avant la randomisation. \nf. Antécédents d’infection oculaire ou périoculaire latente (par ex., syphilis oculaire, maladie de l’œil herpétique)\ng. Antécédents d’hypertension oculaire induite par les stéroïdes ou de glaucome induit par les stéroïdes dans un œil ou l’autre \nh. Pression intraoculaire (PIO) < 6 mmHg (par tonométrie de Goldmann) dans l’œil étudié \ni. Tout antécédent d’hypotonie oculaire ou de dysfonctionnement/pathologie du corps ciliaire dans un œil ou l’autre, tel que déterminé par l’investigateur.\nj. Glaucome ou hypertension intraoculaire nécessitant plus de 2 médicaments topiques pour le contrôle (défini comme une PIO < 22 mmHg) dans l’œil étudié \nk. Toute autre affection oculaire préexistante ou complication chirurgicale qui, selon l’investigateur, empêcherait la participation à un essai clinique interventionnel ou interférerait avec l’interprétation des critères d’évaluation de l’étude.","language":34,"languageDescription":"French (France)"},{"id":10771085,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Szembetegségek: \na. MNV bármelyik szemben az AMD-től eltérő okból \nb. Fibrózis, atrófia vagy szubretinális vérzés a foveális centrális almezőben (1 mm átmérőjű), retina pigmentepithelialis szakadás, makulalyuk, vitreomakuláris trakció, Stargardt-kór, gyógyszer által kiváltott makulopátia, nem nAMD miatti makulaödéma vagy retina neovaszkuláris elzáródás a vizsgált szemben, a szűrési viziten az Olvasóközpont által meghatározottak szerint \nc. Retinaleválás a kórtörténetben a vizsgált szemben \nd. Bármely aktív szemgyulladás vagy aktív szem- vagy periokuláris fertőzés bármelyik szemben (pl. fertőző blepharoconjunctivitis) a szűrési vizit és a randomizálás között bármikor. \ne. Intraokuláris gyulladás (pl. endophthalmitis) vagy uveitis bármelyik szemben, vagy bármely sejt vagy fellángolás jelenléte az elülső csarnokban vagy bármely sejt vagy homályosság a vizsgált szemben bármikor a randomizálás előtt. \nf. Látens okuláris vagy periokuláris fertőzés a kórtörténetben (pl. okuláris szifilisz, herpesz szembetegség) \ng. Szteroid által kiváltott szemészeti hipertónia vagy glaukóma a kórtörténetben, bármelyik szemben \nh. Intraokuláris nyomás (IOP) <6 Hgmm (Goldmann-féle tonometriával kimutatva) a vizsgált szemben \ni. Szemészeti hipotónia vagy ciliaris test diszfunkció/patológia a kórtörténetben, bármelyik szemben, a vizsgáló megítélése szerint.\nj. Glaukóma vagy intraokuláris hipertónia, amely kettőnél több helyileg alkalmazott gyógyszert igényel kontrollálásra (azaz IOP <22 Hgmm) a vizsgált szemben \nk. Bármely más meglévő szembetegség vagy műtéti szövődmény, amely a vizsgáló véleménye szerint kizárja a részvételt egy intervenciós klinikai vizsgálatban, vagy zavarná a vizsgálati végpontok interpretációját.","language":13,"languageDescription":"Hungarian"},{"id":10771087,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Očné ochorenia: \na. MNV z iných príčin ako nAMD v ktoromkoľvek oku \nb. Fibróza, atrofia alebo subretinálne krvácanie v centrálnom foveálnom podpolí (s priemerom 1 mm), trhlina v pigmentovom epiteli sietnice, makulárna diera, vitreomakulárna trakcia, Stargardtova choroba, liekmi vyvolané makulopatie, makulárny edém nie v dôsledku nAMD alebo neovaskulárna oklúzia sietnice v skúšanom oku podľa toho, ako to určí interpretačné centrum pri skríningovej návšteve \nc. Anamnéza odlupovania sietnice v sledovanom oku \nd. Akýkoľvek aktívny očný zápal alebo aktívna očná alebo periokulárna infekcia v ktoromkoľvek oku (napr. infekčná blefarokonjunktivitída) kedykoľvek medzi skríningovou návštevou a randomizáciou. \ne. Anamnéza vnútroočného zápalu (napr. endoftalmitída) alebo uveitídy v ktoromkoľvek oku, alebo prítomnosť akýchkoľvek buniek, prípadne prepuknutie v prednej komore, alebo prítomnosť akýchkoľvek buniek alebo zákalu v sklovci v skúšanom oku kedykoľvek pred randomizáciou. \nf. Anamnéza latentnej očnej alebo periokulárnej infekcie (napr. syfilis oka, herpetické očné ochorenie) \ng. Anamnéza očnej hypertenzie vyvolanej steroidmi alebo glaukómu vyvolaného steroidmi v ktoromkoľvek oku \nh. Vnútroočný tlak (IOP) < 6 mmHg (podľa Goldmannovej tonometrie) v skúšanom oku \ni. Akákoľvek anamnéza očnej hypotónie alebo dysfunkcie/patológie ciliárneho telieska v ktoromkoľvek oku podľa stanovenia skúšajúcim lekárom\nj. Glaukóm alebo vnútroočná hypertenzia vyžadujúca viac ako 2 lokálne lieky na kontrolu (čo je definované ako IOP < 22 mmHg) v skúšanom oku \nk. Akékoľvek iné už existujúce očné stavy alebo chirurgické komplikácie, ktoré by podľa názoru skúšajúceho bránili účasti na intervenčnom klinickom skúšaní alebo by zasahovali do interpretácie ukazovateľov skúšania","language":22,"languageDescription":"Slovak"},{"id":10771084,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Очни състояния: \nа. MNV поради причини, различни от nAMD, в едно от двете очи \nб. фиброза, атрофия или субретинален кръвоизлив във фовеалното централно подполе (1 mm диаметър), разкъсване на пигментния епител на ретината, дупка на макулата, витреомакуларно сцепление, заболяване на Старгарт, индуцирани от лекарства макулопатии, макуларен оток, който не се дължи на nAMD, или неоваскуларна оклузия на ретината, в изследваното око, по преценка на Центъра за разчитане на визитата за скрининг \nв. Анамнеза за отлепване на ретината в изследваното око \nг. Всяко активно очно възпаление или активна очна или околоочна инфекция в едно от двете очи (напр. инфекциозен блефароконюнктивит) по всяко време между визитата за скрининг и рандомизацията. \nд. Анамнеза за вътреочно възпаление (напр. ендофталмит) или увеит в едно от двете очи или наличие на каквито и да било клетки или обостряне в предната камера, или каквито и да било клетки, или замъгленост в стъкловидното тяло на изследваното око, по което и да е време преди рандомизацията. \nе. Анамнеза за латентна очна или околоочна инфекция (напр. очен сифилис, херпетична очна болест) \nж. Анамнеза за индуцирана от стероиди очна хипертония или индуцирана от стероиди глаукома в едно от двете очи \nз. Вътреочно налягане (Intraocular pressure, IOP) <6 mmHg (според тонометрията на Goldmann) в изследваното око \nи. Всяка анамнеза за очна хипотония или дисфункция/патология на цилиарното тяло в едно от двете очи, по преценка на изследователя.\nй. Глаукома или вътреочна хипертония, изискваща повече от 2 локални лекарства за контрол (дефинирани като IOP <22 mm Hg) в изследваното око \nк. Всякакви други предварително съществуващи очни състояния или хирургични усложнения, които по мнението на изследователя биха възпрепятствали участието в интервенционално клинично изпитване или биха попречили на тълкуването на крайните точки по изпитването.","language":1,"languageDescription":"Bulgarian"},{"id":10771083,"uuid":"df9f0c42-0e81-46c0-bcfb-a35b27deb67d","attributeTranslation":"1. Afecciones oculares: \na. NVM por causas distintas a la DMAEn en cualquier ojo. \nb. Fibrosis, atrofia o hemorragia subretiniana en el subcampo central foveal (1 mm de diámetro), desgarro del epitelio pigmentario de la retina, agujero macular, tracción vítreomacular, enfermedad de Stargardt, maculopatías inducidas por fármacos, edema macular no debido a DMAEn u oclusión neovascular de la retina, en el ojo del estudio, según lo determine el centro de lectura en la visita de selección. \nc. Antecedentes de desprendimiento de retina en el ojo del estudio. \nd. Cualquier inflamación ocular activa o infección ocular o periocular activa en cualquiera de los ojos (por ejemplo, blefaroconjuntivitis infecciosa) en cualquier momento entre la visita de selección y la aleatorización. \ne. Antecedentes de inflamación intraocular (p. ej., endoftalmitis) o uveítis en cualquiera de los ojos, o celularidad o presencia de proteínas en la cámara anterior o células o neblina en el vítreo en el ojo del estudio en cualquier momento antes de la aleatorización. \nf. Antecedentes de infección ocular o periocular latente (p. ej., sífilis ocular, enfermedad ocular herpética). \ng. Antecedentes de hipertensión ocular inducida por corticosteroides o glaucoma inducido por corticosteroide en cualquiera de los ojos. \nh. Presión intraocular (PIO) de <6 mmHg (por tonometría de Goldmann) en el ojo del estudio. \ni. Cualquier antecedente de hipotonía ocular o disfunción/patología del cuerpo ciliar en cualquiera de los ojos, según lo determine el investigador.\nj. Glaucoma o hipertensión intraocular que requiera más de 2 medicamentos tópicos para su control (definido como PIO de <22 mmHg) en el ojo del estudio. \nk. Cualquier otra afección ocular preexistente o complicación quirúrgica que, en opinión del investigador, impediría la participación en un ensayo clínico intervencionista o interferiría con la interpretación de los criterios de valoración del estudio.","language":7,"languageDescription":"Spanish"}]},{"id":1496481,"number":2,"principalExclusionCriteria":"Ocular Treatments/Interventions in the Study Eye:  a. Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF, including, but not restricted to IVT therapy (e.g. steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention  b. Aphakia, pseudophakia with anterior chamber intraocular lens, or significant violation of the posterior capsule with the exception of yttrium-aluminum garnet (YAG) with posterior chamber lens implantation   c. History of the following surgeries and procedures: cataract surgery associated with complications, incisional glaucoma surgery (e.g. trabeculectomy), glaucoma tube or shunt placement, pars plana vitrectomy, corneal transplant, sub-macular surgery, retinal detachment surgery, ranibizumab injection implant (Susvimo™), macular laser or extensive panretinal photocoagulation, radiation therapy.  d. Uncomplicated cataract surgery, YAG laser posterior capsulotomy, or glaucoma laser treatment in the 3 months prior to the Screening Visit  e. Any concurrent intraocular condition (e.g. amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the Investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study f. Any prior exposure to brolucizumab","principalExclusionCriteriaTranslations":[{"id":10771092,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Tratamentos/intervenções oculares no olho do estudo: \na. Qualquer tratamento prévio ou concomitante para MNV ou anomalias da interface vitreomacular, além do anti-VEGF IVT permitido, incluindo, mas não se limitando à terapia IVT (por exemplo, esteroides, ativador do plasminogênio tecidual, ocriplasmina, C3F8, ar), intervenção farmacológica periocular, fotocoagulação com laser de argónio, terapia fotodinâmica com verteporfina, laser de diodo, termoterapia transpupilar ou intervenção cirúrgica ocular \nb. Afaquia, pseudofaquia com lente intraocular da câmara anterior, ou violação significativa da cápsula posterior com exceção de ginja de alumínio (YAG) com implante de lente da câmara posterior.\nc. Histórico das seguintes cirurgias e procedimentos: cirurgia de catarata associada a complicações, cirurgia incisional de glaucoma (por exemplo, trabeculectomia), colocação de tubo ou shunt de glaucoma, vitrectomia pars plana, transplante de córnea, cirurgia submacular, cirurgia de descolamento da retina, implante de injeção de ranibizumab (Susvimo™), laser macular ou fotocoagulação panretiniana extensa, radioterapia. \nd. Cirurgia de catarata não complicada, capsulotomia posterior com laser YAG ou tratamento com laser para glaucoma nos 3 meses anteriores à consulta de seleção \ne. Qualquer condição intraocular concomitante (por exemplo, ambliopia, afaquia, descolamento da retina, catarata, retinopatia diabética ou maculopatia, ou membrana epirretiniana com tração) que, na opinião do Investigador, possa reduzir o potencial de melhoria visual ou exigir medicação ou intervenção cirúrgica durante o estudo \nf. Qualquer exposição anterior a brolucizumab","language":20,"languageDescription":"Portuguese"},{"id":10771089,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Traitements oculaires/Interventions dans l’œil étudié : \na. Tout traitement antérieur ou concomitant pour des anomalies de l’interface vitréo-maculaire, autres que les traitements IVT anti-VEGF antérieurs autorisés, y compris, mais sans s’y limiter, un traitement IVT (par ex., stéroïdes, activateur tissulaire du plasminogène, ocriplasmine, C3F8, air), une intervention pharmacologique périoculaire, une photocoagulation au laser à l’argon, une photothérapie verteporfindynamique, un laser à diode, une intervention chirurgicale transpupillaire ou une thermofinaire \nb. Aphakie, pseudophakie avec lentille intraoculaire de chambre antérieure, ou violation significative de la capsule postérieure à l’exception du grenat d’yttrium-aluminium (YAG) avec implantation de lentille de chambre postérieure.\n\nc. Antécédents pour les interventions chirurgicales et les procédures suivantes : chirurgie de la cataracte associée à des complications, chirurgie incisionnelle du glaucome (p. ex., trabéculectomie), pose d’un tube ou d’un shunt contre le glaucome, vitrectomie par la pars plana, greffe de cornée, chirurgie sous-maculaire, chirurgie du décollement de la rétine, implant d’injection de ranibizumab (Susvimo™), photocoagulation maculaire ou panrétinienne étendue au laser, radiothérapie\nd. Chirurgie de la cataracte sans complications, capsulotomie postérieure au laser YAG ou traitement au laser du glaucome dans les 3 mois précédant la visite de sélection \ne. Toute affection intraoculaire concomitante (p. ex., amblyopie, aphakie, décollement de la rétine, cataracte, rétinopathie ou maculopathie diabétique, ou membrane épirétinienne avec traction) qui, de l’avis de l’investigateur, pourrait soit réduire le potentiel d’amélioration de la vision, soit nécessiter une intervention médicale ou chirurgicale pendant l’étude \nf. Toute exposition antérieure au brolucizumab","language":34,"languageDescription":"French (France)"},{"id":10771093,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Očná liečba/intervencie v skúšanom oku: \na. Akákoľvek predchádzajúca alebo súbežná liečba MNV alebo abnormalít vitreomakulárneho rozhrania, okrem povolenej predchádzajúcej IVT liečby anti-VEGF, vrátane (okrem iného) IVT liečby (napr. steroidy, aktivátor tkaninového plazminogénu, okriplazmín, C3F8, vzduch), periokulárnej farmakologickej intervencie, argónovej laserovej fotokoagulácie, fotodynamickej liečby verteporfínom, diódového lasera, transpupilárnej termoterapie alebo očného chirurgického zákroku \n\nb. Afakia, pseudofakia s vnútroočnou šošovkou v prednej komore alebo významné porušenie zadnej kapsuly s výnimkou YAG laserového zákroku s implantáciou šošovky v zadnej komore\n\nc. Anamnéza nasledujúcich chirurgických zákrokov a procedúr: operácia sivého zákalu spojená s komplikáciami, incízna operácia glaukómu (napr. trabekulektómia), zavedenie glaukómovej trubice alebo drenážneho implantátu, pars plana vitrektómia, transplantácia rohovky, submakulárna operácia, operácia odlúčenej sietnice, injekčný implantát s ranibizumabom (Susvimo™), makulárny laser alebo rozsiahla panretinálna fotokoagulácia, rádioterapia \nd. Nekomplikovaná operácia katarakty, zadná kapsulotómia YAG laserom alebo laserová liečba glaukómu v priebehu 3 mesiacov pred skríningovou návštevou \ne. Akýkoľvek súbežný vnútroočný stav (napr. amblyopia, afakia, odlúčenie sietnice, sivý zákal, diabetická retinopatia alebo makulopatia, alebo epiretinálna membrána s trakciou), ktorý by podľa názoru skúšajúceho mohol buď znížiť potenciál na zlepšenie zraku, alebo vyžadovať lekársky či chirurgický zákrok počas skúšania \nf. Akákoľvek predchádzajúca expozícia brolucizumabu","language":22,"languageDescription":"Slovak"},{"id":10771090,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Tratamientos/intervenciones oculares en el ojo del estudio: \na. Cualquier tratamiento previo o concomitante para la NVM o anomalías de la interfaz vítreomacular, además del tratamiento antiVEGF IVT permitido previamente, incluidos, entre otros, el tratamiento IVT (p. ej., corticosteroides, activador del plasminógeno tisular, ocriplasmina, C3F8, aire), intervención farmacológica periocular, fotocoagulación con láser de argón, terapia fotodinámica con verteporfina, láser de diodo, termoterapia transpupilar o intervención quirúrgica ocular. \nb. Afaquia, pseudofaquia con lente intraocular de cámara anterior o violación significativa de la cápsula posterior con excepción del granate de itrio y aluminio (YAG) con implantación de lente de cámara posterior.\nc. Antecedentes de las siguientes cirugías y procedimientos: cirugía de cataratas asociada con complicaciones, cirugía de glaucoma incisional (por ejemplo, trabeculectomía), colocación de tubo de glaucoma o de derivación, vitrectomía a través de la parte plana, trasplante de córnea, cirugía submacular, cirugía por desprendimiento de retina, implante de inyección de ranibizumab (Susvimo™), láser macular o fotocoagulación panretiniana extensa, radioterapia. \nd. Cirugía de cataratas sin complicaciones, capsulotomía posterior con láser YAG o tratamiento con láser para glaucoma en los 3 meses previos a la visita de selección. \ne. Cualquier afección intraocular concurrente (por ejemplo, ambliopía, afaquia, desprendimiento de retina, cataratas, retinopatía o maculopatía diabética o membrana epirretiniana con tracción) que, en opinión del investigador, podría reducir la posibilidad de mejora visual o requerir intervención médica o quirúrgica durante el estudio. \nf. Cualquier exposición previa a brolucizumab.","language":7,"languageDescription":"Spanish"},{"id":10771091,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Очни лечения/интервенции в изследваното око: \nа. Всяка предишна или съпътстваща терапия за MNV или витреомакуларни аномалии на , различни от позволените предходни IVT анти-VEGF, включително, но не ограничени до IVT терапия (напр. стероиди, тъканен плазминогенен активатор, окриплазмин, C3F8, въздух), околоочна фармакологична интервенция, аргон лазерна фотокоагулация, вертепорфин фотодинамична терапия, диоден лазер, трансзенична термотерапия или очна хирургическа интервенция \nб. Афакия, псевдофакия с преднокамерна интраокулярна леща или значително нарушение на задната капсула с изключение на итрий-алуминиев гранат (YAG) с имплантиране на заднокамерни лещи.\nв. Анамнеза за следните операции и процедури: операция на катаракта, свързана с усложнения, операция при инцизионна глаукома (напр. трабекулектомия), поставяне на тръбен шунт при глаукома, витректомия на парс плана, трансплантация на роговица, субмакуларна операция, операция при отлепване на ретината, инжекционен имплант ранибизумаб (Susvimo™), лазерна или екстензивна панретинална фотокоагулация на макулата, лъчетерапия. \nг. Неусложнена операция при катаракта, задна капсулотомия с YAG лазер или лазерно лечение на глаукома през 3-те месеца преди визитата за скрининг \nд. Всяко съпътстващо вътреочно състояние (напр. амблиопия, афакия, отлепване на ретината, катаракта, диабетна ретинопатия или макулопатия, или епиретинална мембрана с тракция), което по мнението на изследователя би могло или да намали потенциала за подобрение на зрението, или да изисква медицинска или хирургическа интервенция по време на изпитването \nе. Всяка предишна експозиция на бролуцизумаб","language":1,"languageDescription":"Bulgarian"},{"id":10771088,"uuid":"5ddd6ec3-db67-440a-9cb4-8b32b3f60279","attributeTranslation":"2. Szemészeti kezelések/beavatkozások a vizsgált szemben: \na. MNV vagy vitreomacularis-interface rendellenességek korábbi vagy egyidejű kezelése, kivéve a megengedett korábbi IVT anti-VEGF kezelést, beleértve, de nem kizárólag, az IVT terápiát (pl. szteroidok, szöveti plazminogén aktivátor, okriplazmin, C3F8, levegő), periokuláris farmakológiai beavatkozás, argon lézer fotokoaguláció, verteporfin fotodinamikus terápia, dióda lézer, transzpupilláris termoterápia vagy okuláris sebészeti beavatkozás \nb. Afákia, pszeudofákia elülső csarnoki intraokuláris műlencsével, vagy a hátsó tok jelentős megsértése, kivéve az ittrium-alumínium garnetet (YAG), hátsó csarnoki lencse beültetéssel.\nc. A következő műtétek és eljárások a kórtörténetben: szövődményekkel járó szürkehályog műtét, metszéses glaukóma-műtét (pl. trabeculectomia), glaukóma cső vagy sönt behelyezése, pars plana vitrectomia, szaruhártya-átültetés, submaculáris műtét, retinaleválás műtét, ranibizumab injektálható implantátum (Susvimo™), makuláris lézerkezelés vagy kiterjedt panretinális fotokoaguláció, sugárkezelés. \nd. Szövődménymentes szürkehályog műtét, YAG lézeres hátsó capsulotomia vagy glaukóma lézeres kezelés a szűrési vizitet megelőző 3 hónapban \ne. Bármilyen egyidejűleg fennálló intraokuláris állapot (pl. amblyopia, aphakia, retinaleválás, szürkehályog, diabéteszes retinopátia vagy makulopátia, illetve trakcióval társuló epiretinális membrán), amely a vizsgáló megítélése szerint csökkentheti a látás javulásának lehetőségét, vagy orvosi vagy sebészi beavatkozást tehet szükségessé a vizsgálat során. \nf. Bármilyen korábbi brolucizumab expozíció.","language":13,"languageDescription":"Hungarian"}]},{"id":1496482,"number":3,"principalExclusionCriteria":"Prior/Concomitant Medications (Systemic or in Either Eye):  a. Receiving or anticipated to receive a systemic drug that inhibits VEGF pathways, e.g. bevacizumab, sunitinib, pazopanib  b. Ever received or anticipated to receive IVT complement inhibitors (e.g. pegcetacoplan, avacincaptad pegol) in either eye  c. History of serious allergy, hypersensitivity, or contraindications to fluorescein and/or trial-specified interventions (e.g. 4D-150 excipients, aflibercept, povidone-iodine)","principalExclusionCriteriaTranslations":[{"id":10771098,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Предишни/Съпътстващи лекарства (системни или в едното око):\n\nа. Получаване или очаквано получаване на системно лекарство, което инхибира пътищата на VEGF, напр. бевацизумаб, сунитиниб, пазопаниб \nб. Получавани или очаквани някога да се получат добавки, инхибитори на IVT (напр. пегцетакоплан, авацинкаптад пегол) в едно от двете очи \nв. Анамнеза за сериозна алергия, свръхчувствителност или противопоказания за флуоресцеин и/или интервенции, специфични за изпитването (напр. помощни вещества 4D-150, афлиберцепт, повидон-йод)","language":1,"languageDescription":"Bulgarian"},{"id":10771099,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Predchádzajúce/súbežne užívané lieky (systémové alebo v ktoromkoľvek oku):\na. Užívanie alebo očakávané užívanie systémového lieku, ktorý inhibuje dráhy VEGF, napr. bevacizumab, sunitinib, pazopanib \nb. Už podané alebo očakávané IVT podanie inhibítorov komplementu (napr. pegcetakoplan, avacincaptad pegol) v ktoromkoľvek oku \nc. Anamnéza závažnej alergie, precitlivenosti alebo kontraindikácií na fluoresceín a/alebo intervencie špecifikované v klinickom skúšaní (napr. pomocné látky 4D-150, aflibercept, jódovaný povidón)","language":22,"languageDescription":"Slovak"},{"id":10771094,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Médicaments antérieurs/concomitants (systémiques ou dans l’un ou l’autre œil) :\na. Recevoir ou prévoir de recevoir un médicament systémique qui inhibe les voies du VEGF, par ex., bévacizumab, sunitinib, pazopanib \nb. Avoir déjà reçu ou recevoir des inhibiteurs de complément IVT (par ex., pegcétacoplan, avacincaptad pégol) dans un œil ou l’autre \nc. Antécédents d’allergie grave, d’hypersensibilité ou de contre-indications à la fluorescéine et/ou aux interventions spécifiées dans l’essai (par ex., excipients 4D-150, aflibercept, povidone iodée)","language":34,"languageDescription":"French (France)"},{"id":10771096,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Medicações anteriores/concomitantes (sistémicas ou em qualquer um dos olhos):\na. A receber ou previsto receber um medicamento sistémico que inibe as vias VEGF, por exemplo bevacizumab, sunitinib, pazopanib \nb. Alguma vez receberam ou prevê-se que recebam inibidores do complemento IVT (por ex. pegcetacoplan, avacincaptad pegol) em qualquer um dos olhos \nc. História de alergia grave, hipersensibilidade ou contraindicações à fluoresceína e/ou intervenções especificadas pelo ensaio (por exemplo, excipientes 4D-150, aflibercept, povidona-ioda)","language":20,"languageDescription":"Portuguese"},{"id":10771097,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Korábban/egyidejűleg alkalmazott gyógyszerek (szisztémásan vagy bármelyik szemben):\na. A beteg olyan szisztémás gyógyszert kap vagy fog kapni, ami gátolja a VEGF-útvonalakat, pl. bevacizumab, sunitinib, pazopanib \nb. Korábban kapott vagy várhatóan kap IVT komplementgátlókat (pl. pegcetacoplan, avacincaptad pegol) bármelyik szemben \nc. A fluoreszceinnel és/vagy a klinikai vizsgálattal összefüggő beavatkozásokkal (pl. 4D-150 segédanyagok, aflibercept, povidon-jód) szembeni súlyos allergia, túlérzékenység, vagy ellenjavallat az anamnézisben","language":13,"languageDescription":"Hungarian"},{"id":10771095,"uuid":"ec92bb77-086f-4a0d-8387-3d7757e75099","attributeTranslation":"3. Medicamentos previos/concomitantes (sistémicos o en cualquiera de los ojos):\na. Recibir o prever recibir un fármaco sistémico que inhibe las vías de VEGF, p. ej., bevacizumab, sunitinib, pazopanib. \nb. Haber recibido o tener previsto recibir alguna vez inhibidores del complemento IVT (p. ej., pegcetacoplán, avacincaptad pegol) en cualquiera de los ojos. \nc. Antecedentes de alergia grave, hipersensibilidad o contraindicaciones a la fluoresceína o a las intervenciones especificadas para el ensayo (p. ej., excipientes 4D-150, aflibercept, povidona yodada).","language":7,"languageDescription":"Spanish"}]},{"id":1496483,"number":4,"principalExclusionCriteria":"Prior Interventional Trial Participation:  a. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months or at least 5 half-lives (whichever is longer) prior to Screening  b. Any prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy","principalExclusionCriteriaTranslations":[{"id":10771101,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Participação em ensaios de intervenção anteriores: \na. Recebeu um medicamento experimental, agente, dispositivo ou terapêutica (ocular ou não ocular) nos 3 meses ou pelo menos 5 semividas (o que for mais longo) antes da Seleção \nb. Qualquer terapia genética anterior (ocular ou não ocular) e/ou terapêutica de células estaminais oculares","language":20,"languageDescription":"Portuguese"},{"id":10771105,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Účasť v predchádzajúcom intervenčnom skúšaní: \na. Podanie skúšaného lieku, látky, poskytnutie pomôcky alebo liečby (očnej alebo neočnej) v priebehu 3 mesiacov alebo najmenej 5 polčasov (podľa toho, čo trvá dlhšie) pred skríningovou návštevou \nb. Akákoľvek predchádzajúca génová terapia (očná alebo neočná) a/alebo očná terapia kmeňovými bunkami","language":22,"languageDescription":"Slovak"},{"id":10771104,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Korábbi intervenciós vizsgálatban való részvétel: \na. Vizsgálati gyógyszert, szert, eszközt vagy (okuláris vagy nem szemészeti) terápiát kapott a szűrés előtti 3 hónapban vagy egy legalább 5 felezési időnek megfelelő időszakban (amelyik hosszabb) \nb. Bármilyen korábbi génterápia (okuláris vagy nem szemészeti) és/vagy szemészeti őssejtterápia","language":13,"languageDescription":"Hungarian"},{"id":10771100,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Предходно участие в интервенционално изпитване: \nа. Получили изпитвано лекарство, продукт, устройство или терапия (очна или неочна) през 3-те месеца или най-малко 5 периода на полуразпад (което е по-дълго) преди скрининга \nб. Всяка предишна генна терапия (очна или неочна) и/или очна терапия със стволови клетки","language":1,"languageDescription":"Bulgarian"},{"id":10771102,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Participación previa en ensayos intervencionistas: \na. Haber recibido un fármaco, agente, dispositivo o tratamiento (ocular o no) en investigación en los 3 meses o al menos 5 semividas (lo que sea más largo) anteriores a la selección. \nb. Haber recibido previamente cualquier genoterapia (ocular o no) o tratamiento ocular de células madre.","language":7,"languageDescription":"Spanish"},{"id":10771103,"uuid":"a5cadacd-9e84-44c1-8ac6-e1235720a595","attributeTranslation":"4. Participation antérieure à un essai interventionnel : \na. Avoir reçu un médicament expérimental, un agent, un dispositif ou un traitement expérimental (oculaire ou non oculaire) au cours des 3 mois ou au moins 5 demi-vies (selon l’éventualité la plus longue) précédant la sélection \nb. Toute thérapie génique antérieure (oculaire ou non oculaire) et/ou thérapie par cellules souches oculaires","language":34,"languageDescription":"French (France)"}]},{"id":1496484,"number":5,"principalExclusionCriteria":"Systemic Conditions and Considerations:  a. Major illness or major surgical procedure in the 28 days prior to the Screening Visit  b. Uncontrolled blood pressure, defined as resting average systolic value ≥160 mmHg and/or average diastolic value ≥100 mmHg, based on triplicate measurements at 1-minute intervals at Screening. If blood pressure exceeds these values, measurements can be repeated up to 3 times within the Screening Visit window. Blood pressure medications should be at stable dose/regimen for at least 28 days prior to Screening.  c. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit  d. Any history of syphilis (whether or not treated)  e. History of autoimmune condition that may predispose to the development of uveitis, including, but not limited to Behcet disease, spondyloarthropathies, multiple sclerosis, HLA-B27 syndrome, Crohn’s disease, sarcoidosis, lupus, or rheumatoid arthritis  f. Any documented active or suspected malignancy, or history of malignancy within 12 months prior to Screening, except appropriately treated/resected localized tumor with low risk for recurrence (e.g. treated local basal cell or squamous cell carcinoma of the skin, noninvasive bladder cancer, prostate cancer stage 1 or 2 with stable prostate-specific antigen for 6 months, or any cancer considered surgically cured)  g. Intercurrent illness or condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk, prevent the subject from completing the trial, or confound interpretation of trial results  h. Female of child-bearing potential, per (CTFG, 2020).","principalExclusionCriteriaTranslations":[{"id":10771109,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Conditions systémiques et considérations : \na. Maladie majeure ou intervention chirurgicale majeure dans les 28 jours précédant la visite de sélection \nb. Tension artérielle non contrôlée, définie comme une valeur systolique moyenne au repos ≥ 160 mmHg et/ou une valeur diastolique moyenne ≥ 100 mmHg, basée sur des mesures en triple à intervalles d’une minute à la sélection. Si la tension artérielle dépasse ces valeurs, les mesures peuvent être répétées jusqu’à 3 fois dans la fenêtre de la visite de sélection. Les médicaments pour la tension artérielle doivent être administrés à une dose/un schéma posologique stable depuis au moins 28 jours avant la sélection. \nc. Syndrome coronarien aigu, infarctus du myocarde ou revascularisation des artères coronaires, accident vasculaire cérébral, accident ischémique transitoire dans les 6 mois précédant la visite de sélection \nd. Tout antécédent de syphilis (traitée ou non) \ne. Antécédents d’affection auto-immune pouvant prédisposer au développement d’une uvéite, y compris, mais sans s’y limiter, la maladie de Behcet, les spondylarthropathies, la sclérose en plaques, le syndrome HLA-B27, la maladie de Crohn, la sarcoïdose, le lupus ou la polyarthrite rhumatoïde \nf. Toute tumeur maligne active ou suspectée documentée, ou antécédents de tumeur maligne dans les 12 mois précédant la sélection, à l’exception d’une tumeur localisée correctement traitée/réséquée à faible risque de récidive (par ex., carcinome basocellulaire ou épidermoïde de la peau local traité, cancer de la vessie non invasif, cancer de la prostate de stade 1 ou 2 avec antigène prostatique spécifique stable pendant 6 mois, ou tout cancer considéré comme guéri chirurgicalement) \ng. Maladie ou affection intercurrente qui, de l’avis de l’investigateur, peut exposer le/la patient(e) à un risque inacceptable, empêcher le/la patient(e) de terminer l’essai ou fausser l’interprétation des résultats de l’essai \nh. Jeune fille en âge d’avoir des enfants selon (CTFG, 2020).","language":34,"languageDescription":"French (France)"},{"id":10771106,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Condições e considerações sistémicas: \na. Doença grave ou procedimento cirúrgico grave nos 28 dias anteriores à Consulta de Seleção \nb. Pressão arterial não controlada, definida como valor sistólico médio em repouso ≥160 mmHg e/ou valor diastólico médio ≥100 mmHg, com base em medições em triplicado em intervalos de 1 minuto na Seleção. Se a pressão arterial exceder estes valores, as medições podem ser repetidas até 3 vezes dentro da janela de Consulta de Seleção. Os medicamentos para a pressão arterial devem estar numa dose/regime estável durante pelo menos 28 dias antes da Seleção. \nc. Síndrome coronária aguda, enfarte do miocárdio ou revascularização da artéria coronária, acidente vascular cerebral, acidente isquémico transitório nos 6 meses anteriores à Consulta de Seleção \nd. Qualquer historial de sífilis (quer seja ou não tratada) \ne. Historial de doenças autoimunes que possam predispor ao desenvolvimento de uveíte, incluindo, mas não se limitando à doença de Behcet, espondiloartropatias, esclerose múltipla, síndrome HLA-B27, doença de Crohn, sarcoidose, lúpus ou artrite reumatoide \nf. Qualquer malignidade ativa ou suspeita documentada, ou historial de malignidade nos 12 meses anteriores à Seleção, exceto tumor localizado tratado/protegido adequadamente com baixo risco de recidiva (por exemplo, células basais locais tratadas ou carcinoma de células escamosas da pele, cancro da bexiga não invasivo, cancro estádio 1 ou 2 com antigénio estável específico da próstata durante 6 meses, ou qualquer cancro considerado cirurgicamente curado) \ng. Doença ou condição concomitante que, na opinião do Investigador, possa colocar o participante em risco inaceitável, impedir o participante de concluir o ensaio ou confundir a interpretação dos resultados do ensaio \nh. Mulher com potencial para engravidar, de acordo com (CTFG, 2020).","language":20,"languageDescription":"Portuguese"},{"id":10771110,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Системни условия и съображения: \nа. Сериозно заболяване или голяма хирургическа процедура в рамките на 28 дни преди визитата за скрининг \nб. Неконтролирано кръвно налягане, дефинирано като средна систолична стойност в покой ≥160 mmHg и/или средна диастолична стойност ≥100 mmHg въз основа на трикратни измервания на 1-минутни интервали на скрининга. Ако кръвното налягане надвиши тези стойности, измерванията могат да се повторят до 3 пъти в рамките на прозореца за визитите за скрининг. Лекарствата за кръвно налягане трябва да бъдат на стабилна доза/режим в продължение на най-малко 28 дни преди скрининга. \nв. Остър коронарен синдром, инфаркт на миокарда или коронарна артериална реваскуларизация, мозъчно-съдов инцидент, преходен исхемичен пристъп в рамките на 6 месеца от визитата за скрининг \nг. Всяка анамнеза за сифилис (независимо дали е лекуван или не) \nд. Анамнеза за автоимунно състояние, което може да предразположи към развитието на увеит, включително, но не само болестта на Бехцет, спондилоартропатии, множествена склероза, HLA-B27 синдром, болест на Крон, саркоидоза, лупус или ревматоиден артрит \nе. Всяко документирано активно или подозирано злокачествено заболяване, или анамнеза за злокачествено заболяване в рамките на 12 месеца преди скрининга, с изключение на подходящо лекуван/резектиран локализиран тумор с нисък риск за рецидив (напр. лекуван локален базално-клетъчен или плоскоклетъчен карцином на кожата, неинвазивен рак на пикочния мехур, рак на простатата стадий 1 или 2 със стабилен специфичен за простатата антиген в продължение на 6 месеца или всеки рак, който се счита за хирургически излекуван) \nж. Съпътстващо заболяване или състояние, което по мнението на изследователя може да изложи участника на неприемлив риск, да попречи на участника да завърши изпитването или да обърка интерпретацията на резултатите от изпитването \nз. Жена с детероден потенциал, според (CTFG, 2020 г.).","language":1,"languageDescription":"Bulgarian"},{"id":10771108,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Afecciones sistémicas y consideraciones: \na. Enfermedad grave o procedimiento quirúrgico mayor en los 28 días anteriores a la visita de selección. \nb. Presión arterial no controlada, definida como un valor sistólico promedio en reposo de ≥160 mmHg o un valor diastólico promedio de ≥100 mmHg, basado en mediciones triplicadas a intervalos de 1 minuto en el momento de la selección. Si la presión arterial supera estos valores, las mediciones se pueden repetir hasta 3 veces dentro del intervalo de la visita de selección. Los medicamentos para la presión arterial deben administrarse a una dosis/pauta estable durante al menos 28 días antes de la selección. \nc. Síndrome coronario agudo, infarto de miocardio o revascularización de la arteria coronaria, accidente cerebrovascular o ataque isquémico transitorio dentro de los 6 meses previos a la visita de selección. \nd. Cualquier antecedente de sífilis (tanto si se trató como si no). \ne. Antecedentes de enfermedades autoinmunitarias que puedan predisponer al desarrollo de uveítis, incluidas, entre otras, enfermedad de Behçet, espondiloartropatías, esclerosis múltiple, síndrome HLA-B27, enfermedad de Crohn, sarcoidosis, lupus o artritis reumatoide. \nf. Cualquier neoplasia maligna activa o sospecha de la misma documentada, o antecedentes de neoplasia maligna en los 12 meses previos a la selección, excepto un tumor localizado tratado/resecado adecuadamente con bajo riesgo de recidiva (por ejemplo, carcinoma basocelular o epidermoide en la piel local tratado, cáncer de vejiga no invasivo, cáncer de próstata en estadio I o II con antígeno prostático específico estable durante 6 meses, o cualquier cáncer considerado curado quirúrgicamente). \ng. Enfermedad o afección intercurrente que, en opinión del investigador, pueda poner al paciente en un riesgo inaceptable, impedir que este complete el ensayo o causar confusión en la interpretación de los resultados del ensayo. \nh. Mujeres en edad fértil, por (CTFG, 2020).","language":7,"languageDescription":"Spanish"},{"id":10771111,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Systémové stavy a aspekty: \na. Závažné ochorenie alebo závažný chirurgický zákrok v priebehu 28 dní pred skríningovou návštevou \nb. Nekontrolovaný krvný tlak, ktorý je definovaný priemernou systolickou hodnotou v pokoji ≥ 160 mmHg a/alebo priemernou diastolickou hodnotou ≥ 100 mmHg, na základe trojnásobných meraní v minútových intervaloch pri skríningovej návšteve. Ak krvný tlak tieto hodnoty prekročí, merania možno zopakovať najviac 3-krát v rámci skríningovej návštevy. Lieky na krvný tlak by mali byť v stabilnej dávke/schéme najmenej 28 dní pred skríningovou návštevou. \nc. Akútny koronárny syndróm, infarkt myokardu alebo revaskularizácia koronárnej artérie, cievna mozgová príhoda, prechodný ischemický atak v priebehu 6 mesiacov pred skríningovou návštevou \nd. Akákoľvek anamnéza syfilisu (bez ohľadu na to, či bol liečený alebo nie) \ne. Anamnéza autoimunitného ochorenia, ktoré môže predisponovať k rozvoju uveitídy, vrátane (okrem iného) Behcetovej choroby, spondyloartropatií, sklerózy multiplex, syndrómu HLA-B27, Crohnovej choroby, sarkoidózy, lupusu alebo reumatoidnej artritídy \nf. Akákoľvek zdokumentovaná aktívna alebo suspektná malignita, alebo malignita v anamnéze v priebehu 12 mesiacov pred skríningovou návštevou, s výnimkou vhodne liečeného/resekovaného lokalizovaného nádoru s nízkym rizikom recidívy (napr. liečený lokalizovaný karcinóm bazálnych alebo skvamocelulárnych buniek kože, neinvazívny karcinóm močového mechúra, rakovina prostaty v 1. alebo 2. štádiu so stabilným prostatickým antigénom počas 6 mesiacov, alebo akýkoľvek karcinóm považovaný za chirurgicky vyliečený) \ng. Pridružené ochorenie alebo stav, ktorý podľa názoru skúšajúceho môže vystaviť účastníka neprijateľnému riziku, zabrániť účastníkovi dokončiť klinické skúšanie alebo skomplikovať interpretáciu výsledkov skúšania \nh. Žena schopná otehotnieť podľa (CTFG, 2020).","language":22,"languageDescription":"Slovak"},{"id":10771107,"uuid":"daf47a74-06ea-4e90-bdfa-c907e6cae764","attributeTranslation":"5. Szisztémás állapotok és megfontolások: \na. Súlyos betegség vagy súlyos sebészeti eljárás a szűrési vizitet megelőző 28 napban \nb. Nem szabályozott vérnyomás, azaz a szűréskor végzett háromszori mérés alapján az átlagos nyugalmi szisztolés érték ≥160 Hgmm és/vagy az átlagos diasztolés érték ≥100 Hgmm. Ha a vérnyomás meghaladja ezeket az értékeket, a mérések legfeljebb háromszor ismételhetők meg a szűrési vizit keretében. A vérnyomáscsökkentő gyógyszereket a szűrés előtt legalább 28 napon át állandó dózisban és állandó séma szerint szedte. \nc. Akut koronária szindróma, miokardiális infarktus vagy koronária-revaszkularizáció, cerebrovaszkuláris esemény, átmeneti ischaemiás roham a szűrési vizit előtti 6 hónapban \nd. Szifilisz a kórtörténetben (akár kezelték, akár nem) \ne. Autoimmun betegség az anamnézisben, amely hajlamosíthat uveitis kialakulására, beleértve, többek között, a Behcet-kórt, a spondyloarthropathiákat, a szklerózis multiplexet, a HLA-B27 szindrómát, a Crohn-betegséget, a sarcoidosist, a lupust és a rheumatoid arthritist \nf. Bármilyen dokumentált aktív vagy gyanított rosszindulatú daganat, vagy rosszindulatú daganat a kórtörténetben a szűrést megelőző 12 hónapon belül, kivéve a megfelelően kezelt/rezekált, lokalizált tumort, aminél alacsony a kiújulás kockázata (pl. kezelt helyi bazálsejtes vagy laphámsejtes bőrkarcinóma, nem invazív hólyagrák, 1. vagy 2. stádiumú prosztatarák stabil prosztataspecifikus antigénnel 6 hónapon át, vagy bármilyen sebészileg gyógyultnak tekintett rák) \ng. Közbenső betegség vagy állapot, amely a vizsgáló véleménye szerint elfogadhatatlan kockázatnak teheti ki az alanyt, megakadályozhatja az alanyt a vizsgálat befejezésében, vagy zavarhatja a vizsgálati eredmények értelmezését \nh. Fogamzóképes nő, (CTFG, 2020).","language":13,"languageDescription":"Hungarian"}]}]},"endPoint":{"primaryEndPoints":[{"id":1024537,"number":1,"endPoint":"Mean change from baseline in BCVA ETDRS letter score at Week 52","isPrimary":true,"endPointTranslations":[{"id":10771041,"uuid":"085b8a16-2392-423c-b2b2-7af0b2584689","attributeTranslation":"A BCVA ETDRS betűpontszám átlagos változása a kiinduláshoz képest az 52. héten","language":13,"languageDescription":"Hungarian"},{"id":10771040,"uuid":"085b8a16-2392-423c-b2b2-7af0b2584689","attributeTranslation":"Cambio medio con respecto al inicio en la puntuación de letras del ETDRS de la MAVC en la semana 52.","language":7,"languageDescription":"Spanish"},{"id":10771042,"uuid":"085b8a16-2392-423c-b2b2-7af0b2584689","attributeTranslation":"Средна промяна спрямо базовото ниво на буквения резултат по BCVA ETDRS в Седмица 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