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One-Time gene injection could end frequent eye shots for wet AMD

NCT ID NCT05903794

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tested a gene therapy called EXG102-031 in 12 people with wet age-related macular degeneration (nAMD), a condition where abnormal blood vessels damage central vision. The therapy was injected into the eye to block these vessels. The main goal was to check safety and tolerability, not yet to prove it works. If safe, larger studies could explore whether it reduces the need for repeated anti-VEGF injections.

What this could mean

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

Active substance
EXG102-031 (a gene therapy injected into the eye to block abnormal blood vessel growth)
What this could lead to
If successful, this could lead to a one-time gene therapy that reduces the need for frequent eye injections in people with wet age-related macular degeneration.
What could go wrong
This is a very early Phase 1 trial with only 12 people, focused on safety. It is too small to prove effectiveness, and gene therapy carries risks like inflammation or vision changes.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2026

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. Male or female, age ≥ 50 years of age; 2. Diagnosis of nAMD and current active lesion in the study eye at Screening; 3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye; 4. Response to anti-VEGF treatment during Screening; 5. The study eye must be a pseudophakic lens (post-cataract surgery status); and 6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening. Exclusion Criteria: 1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye; 2. Presence in the study eye of CNV or macular edema due to causes other than AMD; 3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula; 4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters; 5. Active ocular infection in either eye; 6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye; 7. History of intraocular surgery in the study eye within 90 days of screening; or 8. Prior receipt of any ocular or systemic gene therapy agent.

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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.

Contacts and locations

Locations

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States