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OCU410ST · GARDian3
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
Ensayo de Ocugen, Inc. en Enfermedad de Stargardt.
- Fase
- Fase 2/3
- Estado
- En marcha, sin reclutar
- Participantes
- 51
- Centros
- 14
- Fin del objetivo primario
- sep 2026
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en ago 2023.
Qué mide
Cambio desde el inicio en el tamano de la lesion atrofica medido por autofluorescencia de fondo de ojo (12 months (Screening to 12 months post OCU410ST administration)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPhase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects. Subjects will be enrolled in a 2:1 ratio to either the treatment group (n=34 subjects) or to an untreated control group (n=17 subjects). Phase 1 is complete and closed for enrollment. It was a multicenter, open-label, dose ranging/dose escalation study that enrolled 9 subjects. OCU410ST Phase 1- Retinal Structure and Visual Function Data Results * Safety: Favorable safety and tolerability profile No SAE deemed related to OCU410ST including intraocular inflammation, exudation, endophthalmitis, anterior ischemic optic neuropathy (AIONs) or vasculitis. * Primary Endpoint: Structural Improvement Atrophic lesions grew slower by 48% at 12M in evaluable treated eyes when compared to untreated eyes * Secondary Endpoint: Visual Function (BCVA) 100% evaluable treated eyes demonstrated stabilization or improvement when compared to untreated eyes in visual function OCU410ST Phase 1- Structural and Functional Outcomes at 12M Data Results * The GARDian3 clinical trial for ABCA4- related retinopathies including Stargardt disease builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow-up in evaluable treated eyes compared to untreated eyes * Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes.
Más ensayos de OCGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| OCU410 · ArMaDa | Fase 1/2 | En marcha, sin reclutar | feb 2026 (real) |
| OCU200 · DME | Fase 1 | Reclutando pacientes | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| liMeliGhT | Fase 3 | En marcha, sin reclutar | feb 2027 (prevista) |
| OCU400 Low Dose | Fase 1/2 | En marcha, sin reclutar | mar 2027 (prevista) |
| OCU410 | Fase 3 | Reclutando pacientes | jul 2028 (prevista) |
| OCU400 | no aplica | Disponible por acceso ampliado | sin fecha |
Todos los de OCGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05956626), actualizada en jul 2026.