Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Geographic Atrophy

In brief

This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 60 subjects.

Key facts

Study ID

NCT06018558

Run by

Ocugen

People needed

60

Starts

2023-02-23

Expected to finish

2030-02-03

Last updated by the study team

2026-07-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 50 years of age or older.
• BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent).
• Fundus autofluorescence (FAF) imaging shows:
• Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk areas [DA], respectively)
• If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3.a
• 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
• Presence of any pattern of hyper-autofluorescence in the junctional zone of GA
• Subjects who had prior treatment with an approved drug for AMD, e.g. Izerway® (Avacincaptad pegol) or Syfovre® (Pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye. Subjects can receive an approved drug for AMD in the fellow eye, if required.

You may not qualify if…

• Previous treatment with a gene-therapy or cell therapy product
• 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., pavingstone degeneration).
• 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.
• Any history or current evidence of exudative ("wet") AMD 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.

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Advanced Research, LLC — Coral Springs, Florida, United States
• Miidwest Eye Institute — Carmel, Indiana, United States
• Mississippi Retina Associates — Jackson, Mississippi, United States
• The Retina Institute — St Louis, Missouri, United States
• Mid Atlantic Retina — Cherry Hill, New Jersey, United States
• Duke Eye Center — Durham, North Carolina, United States
• The University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• B) Retina Consultants of Texas — Bellaire, Texas, United States
• A) Retina Foundation of the Southwest — Dallas, Texas, United States
• Valley retina Institute — McAllen, Texas, United States
• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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