Can a One-Time gene therapy stop the march of dry AMD?
NCT ID NCT07770828
First seen Aug 18, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether a single injection of OCU410, a gene therapy, can slow the growth of geographic atrophy—an advanced form of dry age-related macular degeneration that causes blind spots. About 237 adults aged 55 and older with the condition will be randomly assigned to receive OCU410 or a control. The main goal is to measure changes in the size of the damaged area over 12 months, with a focus on preserving vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OCU410, a gene therapy delivered by a single subretinal injection
- What this could lead to
- If successful, this could become a one-time treatment that slows the progression of geographic atrophy, potentially preserving vision in people with dry AMD.
- What could go wrong
- The trial is still in phase 3, and results may not confirm benefit. Subretinal injection carries risks like bleeding, infection, or retinal detachment, and the effect may not last.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 237 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Erie Retina Research
NOT_YET_RECRUITINGErie, Pennsylvania, 16505, United States
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Valley Retina Institute
RECRUITINGMcAllen, Texas, 78503, United States
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associated Retina Consultants
NOT_YET_RECRUITINGPhoenix, Arizona, 85381, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Light pulses to the eye: a new hope against dry AMD?
- Could a daily electric zap to the eye preserve sight in dry AMD?
- Could light therapy help save sight in dry macular degeneration?
- Gene therapy injection aims to treat dry AMD
- AI eye scanner could catch retina disease earlier
- Bionic implant shows promise for restoring sight in dry AMD