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Gene therapy trial aims to halt blindness in dry AMD

NCT ID NCT06018558

Disease control Sponsor: Ocugen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a gene therapy called OCU410 for geographic atrophy, a severe form of dry age-related macular degeneration that causes vision loss. About 60 adults aged 50 and older will receive a single injection of OCU410 into the eye. Researchers will monitor safety and check if the treatment can preserve or improve vision over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OCU410 (gene therapy)
What this could lead to
If successful, this could lead to a treatment that slows or stops vision loss from geographic atrophy in dry age-related macular degeneration.
What could go wrong
This is an early phase 1/2 trial with only 60 participants, so results may not confirm effectiveness or safety. Gene therapy carries risks like inflammation or immune reactions.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

60 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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 50 years of age or older. 2. BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent). 3. Fundus autofluorescence (FAF) imaging shows: 1. Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk areas \[DA\], respectively) 2. 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 3. 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. Presence of any pattern of hyper-autofluorescence in the junctional zone of GA 4. 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. 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., pavingstone 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 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.

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Conditions

The condition(s) this trial relates to.

dry age related macular degeneration Geographic Atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Geographic atrophy

Contacts and locations

Locations

  • A) Retina Foundation of the Southwest

    Dallas, Texas, 75231, United States

  • Advanced Research, LLC

    Coral Springs, Florida, 33067, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • B) Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Duke Eye Center

    Durham, North Carolina, 27710, United States

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, United States

  • Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034, United States

  • Miidwest Eye Institute

    Carmel, Indiana, 46290, United States

  • Mississippi Retina Associates

    Jackson, Mississippi, 39202, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • The University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • Valley retina Institute

    McAllen, Texas, 78503, United States

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