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Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD
RecruitingPhase 3
A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
Who can join
Ages 55 and older · All sexes
Full eligibility criteria
Inclusion Criteria:
1. Subjects 55 years of age or older at consent.
2. BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye.
3. Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas \[DA\], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy.
4. Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)
5. Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.
Exclusion Criteria:
1. Previous treatment with a gene-therapy or cell therapy product.
2. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
3. Spherical equivalent of the refractive error demonstrating \> 6 diopters of myopia or an axial length \>26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
4. Any history or current evidence of exudative ("wet") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.
5. Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.About the study
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm
What is being tested
- OCU410 (biological)
Sponsor: Ocugen · Participants: 237 · Started: Aug 11, 2026
Contact the study team
- Umair Qazi, MD., MPH · Phone: 12028170787
- Payton Marvel, M.S · Phone: 484-443-3200
Official record on ClinicalTrials.gov — NCT07770828
Locations in the U.S.
| Arizona | associated Retina Consultants, Phoenix (Not yet recruiting) |
| Pennsylvania | Erie Retina Research, Erie (Not yet recruiting) |
| Texas | Valley Retina Institute, McAllen |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.