{"ctNumber":"2025-525008-12-00","ctStatus":"Authorised","decisionDate":"2026-06-25T12:59:00.891","publishDate":"2026-08-15T03:37:50.527072927","ctPublicStatusCode":2,"authorizedApplication":{"authorizedPartI":{"id":136637,"rowSubjectCount":0,"products":[{"id":568623,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11766316","productPharmForm":"SOLUTION FOR INJECTION","euMpNumber":"PRD11766316","prodAuthStatus":1,"pharmForm":"SOLUTION FOR INJECTION","sponsorProductCode":"PST-611","activeSubstanceName":"PST-611","euSubstNumber":"SUB409289","nameOrg":"PULSESIGHT THERAPEUTICS","productSubstances":[{"productPk":"11766316","substancePk":"409291","nameOrg":"PULSESIGHT THERAPEUTICS","substanceOrigin":"Nucleic Acid","actSubstOrigin":"Nucleic Acid","actSubstName":"PST-611","substanceEvCode":"SUB409289"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":true,"orphanDrugDesigNumber":"0000039389","doseUom":"µg microgram(s)","maxDailyDoseAmount":"00","doseUomTotal":"µg microgram(s)","maxTotalDoseAmount":"00","maxTreatmentPeriod":52,"timeUnitCode":"2","evCode":"PRD11766316","sponsorProductCodeEdit":"PST-611","therapies":[{"id":7342,"advancedTherapyType":"3","isInVivo":true}],"devices":[{"id":22468,"productUseDeviceCode":"2","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["7"],"routes":["INTRAOCULAR USE"],"allSubstancesChemicals":false,"jsonActiveSubstanceNames":"pst-611","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"An open-label multiple dose safety, tolerability and exploratory efficacy clinical trial of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration","fullTitleTranslations":[{"id":11487243,"uuid":"ea3f0443-7662-46ef-96fe-eb7fb888b3db","attributeTranslation":"Essai clinique en ouvert, évaluant la sécurité, la tolérance et les signaux d’efficacité de l’administration de doses multiples de PST-611 chez des patients atteints d’atrophie géographique secondaire à une dégénérescence maculaire liée à l’âge","language":10,"languageDescription":"French"}],"publicTitle":"An open-label multiple dose safety, tolerability and exploratory efficacy clinical trial of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration","publicTitleTranslations":[{"id":11487254,"uuid":"ba7805fa-69c0-4654-9ace-96c74d9cd747","attributeTranslation":"Essai clinique en ouvert, évaluant la sécurité, la tolérance et les signaux d’efficacité de l’administration de doses multiples de PST-611 chez des patients atteints d’atrophie géographique secondaire à une dégénérescence maculaire liée à l’âge","language":10,"languageDescription":"French"}],"shortTitle":"PST-611-CT2","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"Phase IIa trial","trialCategoryId":126094},"medicalCondition":{"partIMedicalConditions":[{"id":142924,"medicalCondition":"Geographic atrophy secondary to age-related macular degeneration","medicalConditionTranslations":[{"id":11487223,"uuid":"03f94cee-901a-4af7-ae92-6e140f1c3853","attributeTranslation":"Atrophie géographique secondaire à une dégénérescence maculaire liée à l’âge","language":10,"languageDescription":"French"}],"isConditionRareDisease":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":414950},{"code":"3","trialScopeId":414952},{"code":"5","trialScopeId":414951}],"mainObjective":"To evaluate safety and tolerability of multiple doses of PST-611","mainObjectiveTranslations":[{"id":11487253,"uuid":"b394aad3-cc8f-4293-98fa-c66f3a955087","attributeTranslation":"Evaluer la sécurite et la tolérabilité du PST-611 en administration de doses multiples.","language":10,"languageDescription":"French"}],"secondaryObjectives":[{"id":487053,"number":1,"secondaryObjective":"To assess changes over time in standard ophthalmic examinations, for safety evaluation","secondaryObjectiveTranslations":[{"id":11487255,"uuid":"51f5c676-b427-4fcd-8f3d-4c84a826374a","attributeTranslation":"Évaluer les changements au cours du temps des examens ophtalmologiques standards, dans le cadre de l’évaluation de la sécurité","language":10,"languageDescription":"French"}]},{"id":487054,"number":2,"secondaryObjective":"To assess changes over time in standard ophthalmic examinations, for safety and exploratory efficacy evaluation","secondaryObjectiveTranslations":[{"id":11487256,"uuid":"3c64be80-62d1-44af-89be-30b4c4f8ab80","attributeTranslation":"Évaluer les changements au cours du temps des examens ophtalmologiques standards, dans le cadre de l’évaluation de la sécurité et l’exploration de l’efficacité.","language":10,"languageDescription":"French"}]},{"id":487055,"number":3,"secondaryObjective":"To assess changes over time in novel visual function and retinal morphology examinations, for exploratory efficacy evaluation","secondaryObjectiveTranslations":[{"id":11487257,"uuid":"c2b83f7e-2025-4e38-94f8-3d6478878436","attributeTranslation":"Évaluer les changements au cours du temps d’examens innovants de la fonction visuelle et de la morphologie rétinienne, dans le cadre de l’exploration de l’efficacité.","language":10,"languageDescription":"French"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":928417,"number":1,"principalInclusionCriteria":"Subjects must give written informed consent, be able to make the required trial visits and follow instructions.","principalInclusionCriteriaTranslations":[{"id":11487244,"uuid":"cda29215-eec0-4a44-ac7d-58607fde5010","attributeTranslation":"Les sujets doivent fournir un consentement éclairé écrit, être en mesure d’effectuer les visites requises par l’essai et de suivre les instructions de l’étude.","language":10,"languageDescription":"French"}]},{"id":928418,"number":2,"principalInclusionCriteria":"Female and male subjects must be 65 years of age or older.","principalInclusionCriteriaTranslations":[{"id":11487245,"uuid":"cec17b1c-7ad1-4f68-924e-2cbe40b9e373","attributeTranslation":"Les sujets, femmes ou hommes, doivent être âgés de 65 ans ou plus","language":10,"languageDescription":"French"}]},{"id":928419,"number":3,"principalInclusionCriteria":"In the study eye (SE): cRORA must be present at OCT and attributed to AMD, as evaluated by the Investigator.  cRORA is defined on OCT by (1) presence of a region of hypertransmission of at least 250 µm in diameter in any lateral dimension, and (2) presence of a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, and (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear (Sadda et al., 2018).  All the above listed criteria are to be met for presence of cRORA.","principalInclusionCriteriaTranslations":[{"id":11487246,"uuid":"9c4e393a-3686-44d4-a03f-f31d9d80cab2","attributeTranslation":"Dans l’œil étudié (SE) : une atrophie complète du RPE et de la rétine externe (cRORA) doit être présente à l’OCT et attribuable à une dégénérescence maculaire liée à l’âge (AMD), selon l’évaluation de l’investigateur.\nLa cRORA est définie à l’OCT par :\n(1) la présence d’une zone d’hypertransmission d’au moins 250 µm sur le plus grand axe;\n(2) la présence d’une zone d’atténuation ou d’interruption du RPE (épithélium pigmentaire rétinien) d’au moins 250 µm sur le plus grand axe ;\n(3) la présence de signes de dégénérescence des photorécepteurs sus-jacents ; et\n(4) l’absence de RPE roulé (« scrolled RPE ») ou d’autres signes de déchirure du RPE (Sadda et al., 2018).\n\nTous les critères ci-dessus doivent être remplis pour confirmer la présence d’une cRORA.","language":10,"languageDescription":"French"}]},{"id":928420,"number":4,"principalInclusionCriteria":"Fixation, either central or eccentric, of both eyes, must be compatible with the performance of the ocular imaging and functional assessments included in the trial, as evaluated by the Investigator. The incapacity to fully perform exploratory assessments or optional exploratory assessments is not a reason for not selecting a subject when all other inclusion and exclusion criteria are met.","principalInclusionCriteriaTranslations":[{"id":11487247,"uuid":"03629b98-7ddd-435e-aa85-a52fbe604a43","attributeTranslation":"La fixation, centrale ou excentrée, des deux yeux doit être compatible avec la réalisation des examens d’imagerie oculaire et des évaluations fonctionnelles prévus dans l’essai, selon l’appréciation de l’investigateur.\nL’incapacité à réaliser entièrement les évaluations exploratoires ou les évaluations exploratoires optionnelles ne constitue pas un motif de non-sélection d’un sujet lorsque tous les autres critères d’inclusion et d’exclusion sont respectés.","language":10,"languageDescription":"French"}]},{"id":928421,"number":5,"principalInclusionCriteria":"Participants must be affiliated to social security insurance (if applicable, in accordance with local/applicable regulations).","principalInclusionCriteriaTranslations":[{"id":11487248,"uuid":"56236e8f-6726-4cad-b466-6602ebe277e7","attributeTranslation":"Les participants doivent être affiliés à un régime de sécurité sociale (le cas échéant, conformément aux réglementations locales/applicables).","language":10,"languageDescription":"French"}]},{"id":928422,"number":6,"principalInclusionCriteria":"Documented recent history (i.e., over 3 to 12 months prior to first PST-611 administration) of GA lesion area progression, with a yearly growth projection of ≥ 1.6 mm2, in the SE","principalInclusionCriteriaTranslations":[{"id":11487249,"uuid":"c796ce75-b8c7-4f18-a81c-665740bde7be","attributeTranslation":"Antécédent récent documenté (3 à 12 mois avant la première administration) de la progression de la zone d’atrophie géographique, avec une projection de croissance annuelle dans l’oeil étudié ≥ 1,6 mm2.","language":10,"languageDescription":"French"}]},{"id":928423,"number":7,"principalInclusionCriteria":"GA lesion area prior to the first PST-611 administration must be between 1.25 mm2 and 16 mm2, as assessed by OCT, in SE. If peripapillary atrophy is present, the GA lesion area must be separate from the peripapillary atrophy and not be expected to merge with the peripapillary atrophy during the trial.","principalInclusionCriteriaTranslations":[{"id":11487250,"uuid":"f1e8c4d9-dcc8-43b2-a891-932fcc948227","attributeTranslation":"La surface de la zone atrophique (évaluée par OCT) avant la première administration de PST-611 doit être comprise entre 1.25 mm2 et 16 mm2. En présence d’une atrophie péripapillaire, la zone de lésion doit être distincte de l’atrophie péripapillaire et ne doit pas être susceptible de fusionner avec celleci durant l’étude.","language":10,"languageDescription":"French"}]},{"id":928424,"number":8,"principalInclusionCriteria":"If both eyes are eligible, the SE will be selected by the Investigator based on the totality of the clinical evaluation, including, e.g., projected GA lesion area growth rate and ease of treatment administration procedure performance.","principalInclusionCriteriaTranslations":[{"id":11487251,"uuid":"cf5e1bf1-b351-4900-9169-00488ca7a497","attributeTranslation":"Dans le cas où les 2 yeux sont éligibles, l’oeil étudié sera sélectionné par l’investigateur sur la base de l’intégralité de l’évaluation clinique, incluant la vitesse de croissance projetée de la zone atrophique et la facilité d’exécution de la procédure d’administration du traitement.","language":10,"languageDescription":"French"}]},{"id":928425,"number":9,"principalInclusionCriteria":"Best-Corrected Visual Acuity (BCVA) must be ≤ 75 ETDRS letters (Snellen ≤ 20/32) in the SE","principalInclusionCriteriaTranslations":[{"id":11487252,"uuid":"985d4673-cebf-49c6-99b6-8fdb53af70be","attributeTranslation":"L’acuité visuelle la mieux corrigée (AVMC) doit être ≤ 75 lettres ETDRS\n(Snellen ≤ 20/32) dans l’oeil étudié","language":10,"languageDescription":"French"}]}],"principalExclusionCriteria":[{"id":1586876,"number":1,"principalExclusionCriteria":"Both eyes (OU): any active intraocular or periocular infection or inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis), or history of intraocular or periocular infection or inflammation in the 12 weeks (84 days) prior to Dose 1, the first PST-611 administration.","principalExclusionCriteriaTranslations":[{"id":11487228,"uuid":"abd00efa-e6df-45cc-9557-0ab2dc4bd1d5","attributeTranslation":"Deux yeux (OU) : Présence de toute infection ou inflammation intraoculaire ou périoculaire active (par ex. blépharite infectieuse, conjonctivite infectieuse, kératite, sclérite, endophtalmie), ou d’antécédents d’infection ou d’inflammation intraoculaire ou périoculaire dans les 12 semaines (84 jours) précédant la première administration de PST-611 (Dose 1).","language":10,"languageDescription":"French"}]},{"id":1586877,"number":10,"principalExclusionCriteria":"SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the Screening and Trial Baseline (E1) Visits.","principalExclusionCriteriaTranslations":[{"id":11487229,"uuid":"c8b5c093-0495-404c-8e66-fd583c9b35f3","attributeTranslation":"Œil étudié : sujet présentant une hypertonie oculaire non contrôlée ≥ 25 mmHg dans l’œil étudié lors de la visite de sélection et de la visite de référence de l’essai (E1).","language":10,"languageDescription":"French"}]},{"id":1586878,"number":11,"principalExclusionCriteria":"SE: subject with intraocular hypotension (<6 mmHg) in the SE that in the opinion of the Investigator would interfere with the PST-611 administrations or the evaluation of its safety or efficacy.","principalExclusionCriteriaTranslations":[{"id":11487230,"uuid":"e1d039a7-ba37-491c-b356-b67cfb5320b0","attributeTranslation":"Œil étudié : sujet présentant une hypotonie oculaire (< 6 mmHg) dans l’œil étudié qui, selon l’avis de l’investigateur, interférerait avec l’administration de PST-611 ou avec l’évaluation de sa sécurité ou de son efficacité.","language":10,"languageDescription":"French"}]},{"id":1586879,"number":12,"principalExclusionCriteria":"SE: subject with history of scleritis, scleral thinning, cicatrizing conjunctival diseases, severe ocular allergies, severe ocular surface disease, ocular scarring or intraocular hardware (e.g., retained implant device) that could interfere with the PST-611 administrations or the evaluation of its safety.","principalExclusionCriteriaTranslations":[{"id":11487231,"uuid":"1d4fe24f-ef31-4ef6-b37f-185dfeff33ba","attributeTranslation":"Œil étudié : sujet présentant des antécédents de sclérite, d’amincissement scléral, de tissu cicatriciel conjonctival, d’allergies oculaires sévères, de maladie grave de la surface oculaire, de cicatrices oculaires ou de matériel intraoculaire (par ex. dispositif implanté retenu) susceptibles d’interférer avec l’administration de PST-611 ou avec l’évaluation de sa sécurité.","language":10,"languageDescription":"French"}]},{"id":1586880,"number":13,"principalExclusionCriteria":"SE: any other concurrent ocular surface or intra-ocular condition, including retinal disease other than AMD, which, in the opinion of the Investigator, may pose a safety risk for the PST-611 administrations or interfere with the evaluation of its safety.","principalExclusionCriteriaTranslations":[{"id":11487232,"uuid":"a738ce62-16dd-4ed1-83c8-6933b777aaa9","attributeTranslation":"Œil étudié : toute autre affection concomitante de la surface oculaire ou des tissus intraoculaires, y compris toute maladie rétinienne autre que la DMLA, qui, selon l’avis de l’investigateur, peut représenter un risque pour la sécurité lors de l’administration de PST-611 ou interférer avec l’évaluation de sa sécurité.","language":10,"languageDescription":"French"}]},{"id":1586881,"number":14,"principalExclusionCriteria":"Subject previously exposed to any gene therapy product other than the non- viral gene therapy PST-611.","principalExclusionCriteriaTranslations":[{"id":11487233,"uuid":"f846ba03-d151-45af-98b2-3b28c809c370","attributeTranslation":"Sujet précédemment exposé à tout produit de thérapie génique autre que PST-611.","language":10,"languageDescription":"French"}]},{"id":1586882,"number":15,"principalExclusionCriteria":"Subject legally incapacitated or having limited legal capacity falling under articles L1121-6 and L1121-8 of French Health Code","principalExclusionCriteriaTranslations":[{"id":11487234,"uuid":"dd9781a8-b2a8-43a0-b2e8-ef7e05f6959f","attributeTranslation":"Sujet sous protection juridique ou ayant une capacité juridique limitée conformément aux articles L1121-6 et L1121-8 du Code de la Santé Publique.","language":10,"languageDescription":"French"}]},{"id":1586883,"number":2,"principalExclusionCriteria":"Subject has any condition, which in the opinion of the Investigator, could compromise the subject’s safety or adherence to the trial protocol or follow-up","principalExclusionCriteriaTranslations":[{"id":11487235,"uuid":"eb9a16f8-fc29-47d2-9264-729bf6288492","attributeTranslation":"Sujet présentant toute pathologie qui, selon l’avis de l’investigateur, pourrait compromettre sa sécurité, son adhésion au protocole de l’essai ou son suivi","language":10,"languageDescription":"French"}]},{"id":1586884,"number":3,"principalExclusionCriteria":"Known/suspected hypersensitivity to any standard of care topical or local analgesics/anesthetics or other standard of care treatments used in the preparation of PST-611 administration procedure.","principalExclusionCriteriaTranslations":[{"id":11487236,"uuid":"b96d296a-ce06-4658-84b4-65570e89b067","attributeTranslation":"Hypersensibilité connue ou suspectée à tout analgésique ou anesthésique topique ou local utilisé en pratique standard, ou à tout autre traitement standard utilisé en routine pour la préparation de la procédure d’administration de PST-611.","language":10,"languageDescription":"French"}]},{"id":1586885,"number":4,"principalExclusionCriteria":"Treatment with investigational medicinal products in the 12 weeks (84 days) prior to Dose 1, the first PST-611 administration.","principalExclusionCriteriaTranslations":[{"id":11487237,"uuid":"8bac054f-80f4-4109-800d-43524ad8e7ad","attributeTranslation":"Traitement par des médicaments expérimentaux dans les 12 semaines (84 jours) précédant la première administration de PST-611 (Dose 1).","language":10,"languageDescription":"French"}]},{"id":1586886,"number":5,"principalExclusionCriteria":"Subjects who lack a sufficient command of French language to give a written informed consent in that language.","principalExclusionCriteriaTranslations":[{"id":11487238,"uuid":"d7d79ccb-836c-41b4-a8c3-d0fd16532930","attributeTranslation":"Sujets ne maîtrisant pas suffisamment la langue française pour pouvoir fournir un consentement éclairé écrit dans cette langue.","language":10,"languageDescription":"French"}]},{"id":1586887,"number":6,"principalExclusionCriteria":"SE: any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection in the 12 weeks (84 days) prior to Dose 1, the first PST-611 administration.","principalExclusionCriteriaTranslations":[{"id":11487239,"uuid":"6e3d6bb5-9b96-4878-a0eb-d03cc6852d73","attributeTranslation":"Œil étudié : toute chirurgie intraoculaire (y compris la chirurgie de la cataracte) ou injection intravitréenne (IVT) ou périoculaire de corticostéroïdes dans les 12 semaines (84 jours) précédant la première administration de PST-611 (Dose 1).","language":10,"languageDescription":"French"}]},{"id":1586888,"number":7,"principalExclusionCriteria":"SE: the documented need for more than 2 anti-VEGF IVT treatments per year as well as any anti-VEGF IVT treatment within 3 months prior to Dose 1, the first dose of PST-611, and lesion must be clinically inactive. A history of wet AMD in the SE is not an exclusion criterion.","principalExclusionCriteriaTranslations":[{"id":11487240,"uuid":"0ff90829-b22b-4b5d-8341-350c741a4a43","attributeTranslation":"Œil étudié : le besoin documenté de plus de deux traitements intravitréens (IVT) d’anti-VEGF par an, ainsi que tout traitement IVT d’anti-VEGF dans les 3 mois précédant la première administration de PST-611 (Dose 1), la lésion doit être cliniquement inactive. Un antécédent d’une forme humide de la dégénérescence maculaire liée à l’âge (AMD) dans l’œil étudié ne constitue pas un critère d’exclusion.","language":10,"languageDescription":"French"}]},{"id":1586889,"number":8,"principalExclusionCriteria":"SE: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period.","principalExclusionCriteriaTranslations":[{"id":11487241,"uuid":"42ca2afb-bcc8-49c8-9895-43ad43fadec3","attributeTranslation":"Œil étudié  : opacité des éléments transparents de l’œil interférant avec la réalisation d’une imagerie du fond d’œil ou susceptible de nécessiter une intervention chirurgicale pendant la période de l’essai.","language":10,"languageDescription":"French"}]},{"id":1586890,"number":9,"principalExclusionCriteria":"SE: subject with history of glaucoma filtering surgery (e.g., trabeculectomy or aqueous shunt implant) or who underwent eye surgery in the 12 weeks (84 days) prior to Dose 1, the first PST-611 administration.","principalExclusionCriteriaTranslations":[{"id":11487242,"uuid":"44e4d8d6-aabe-4962-bc6e-f94a2f4490f0","attributeTranslation":"Œil étudié : sujet ayant des antécédents de chirurgie du glaucome (par ex. trabéculectomie ou implant de drainage de l’humeur aqueuse) ou ayant subi une chirurgie de l’œil dans les 12 semaines (84 jours) précédant la première administration de PST-611 (Dose 1).","language":10,"languageDescription":"French"}]}]},"endPoint":{"primaryEndPoints":[{"id":1084809,"number":1,"endPoint":"•\tOcular AEs and TEAEs (incl. 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