NCT07770828 · Ocugen
Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD
What this study is about
This study is a Phase 3 conducted at multiple hospitals, randomly assigned, controlled, assessor blinded, adaptive study in which subjects will be randomly assigned in a 2:1(OCU410: control) ratio to treatment treatment group$1 or control treatment group$1
View original scientific description
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
Interventions
BIOLOGICAL
OCU410
Subretinal Injection
Primary outcome measures
Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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., paving stone 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 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.
Where
- Phoenix, Arizona
- Erie, Pennsylvania
- McAllen, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations