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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 55 and up

OCU410 for Geographic Atrophy due to Dry AMD: treatment to help the eye

Official title: A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration

Run by Ocugen · NCT07770828 · Data updated 2026-11-12

A Phase 3 trial tests whether a single subretinal injection of OCU410 can help people 55 and older with geographic atrophy from dry AMD.

More Age-Related Macular Degeneration trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages55 Years and up
SexAll
Enrollment237 (estimated)
SponsorOcugen
Industry-sponsored
Locations3 sites (Phoenix, Arizona and 2 other locations)
StatusRecruiting
StartedAugust 11, 2026
Main results expectedJuly 30, 2028
Study endsJuly 30, 2031
Registry record updatedAugust 19, 2026
Trial IDNCT07770828 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 55+ with defined GA area on imaging and adequate baseline visual acuity who have no active CNV and meet all study imaging criteria.

Probably not a fit

Patients with GA outside the specified area, very poor vision, active eye disease, or other exclusion criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, controlled, assessor-blinded Phase 3 study comparing a single subretinal injection of OCU410 to no treatment. Participants are randomized 2:1 to receive OCU410 in the study eye or be in the untreated control group for 12 months. The trial uses adaptive design features and will assess efficacy, safety, and tolerability in geographic atrophy due to dry AMD. Eligibility requires specific vision and GA area criteria, stable fellow-eye CNV history, and other ocular imaging findings. Enrollment targets 237 participants across three retina clinics.

Why it matters

Potential benefit: If successful, OCU410 could slow progression or reduce vision loss from geographic atrophy in dry AMD.

How similar studies have gone: Previous similar approaches in GA have shown mixed results; this study explores a new therapeutic in a rigorous Phase 3 framework.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Valley Retina Institute
    McAllen, Texas, United States     Recruiting
  • associated Retina Consultants
    Phoenix, Arizona, United States     Not yet recruiting
  • Erie Retina Research
    Erie, Pennsylvania, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.