Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD

NCT07770828 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: OCU410-301
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Dry Age-related Macular Degeneration

Keywords

Geographical Atrophy; Dry Age Related

Outcome Measures

Primary Outcomes (1)

• Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12

  Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements

  Month 12

Secondary Outcomes (2)

• Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12

  Month 12

• Rate of change of ellipsoid zone (EZ) area loss at Month 12

  Month 12

Study Arms (2)

OCU410

EXPERIMENTAL

OCU410 Single Sub Retinal Injection, 200 µL, 1×10\^10 vg/eye

Biological: OCU410

Untreated Control Arm

NO INTERVENTION

Control Arm (Untreated)

Interventions

OCU410 BIOLOGICAL

Subretinal Injection

OCU410

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 55 years of age or older at consent.
• 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.
• 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.
• 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)
• 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.

You may not qualify if:

• Previous treatment with a gene-therapy or cell therapy product.
• 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 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.
• Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.

Sponsors & Collaborators

• Ocugen: lead

Study Sites (3)

associated Retina Consultants

Phoenix, Arizona, 85381, United States

NOT YET RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

NOT YET RECRUITING

Valley Retina Institute

McAllen, Texas, 78503, United States

RECRUITING

Study Officials

• Mohamed Genead, MD

  Ocugen., Inc.

  STUDY CHAIR

• Jennifer Henrick

  Ocugen., Inc

  STUDY DIRECTOR

Central Study Contacts

Umair Qazi, MD., MPH

CONTACT

12028170787; umair.qazi@ocugen.com

Payton Marvel, M.S

CONTACT

484-443-3200; payton.marvel@ocugen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor Masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, controlled, assessor masked study

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2031
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

US (3)