One-Shot gene therapy aims to end monthly eye injections for wet AMD

NCT ID NCT07178249

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This early-stage trial tests EXG202, a gene therapy given as a single injection into the eye for people with wet age-related macular degeneration (AMD). The goal is to see if it is safe and can produce a protein that blocks abnormal blood vessel growth long-term, potentially reducing the need for frequent anti-VEGF injections. About 60 participants aged 50 and older with active wet AMD will be enrolled.

What this could mean

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

Active substance
EXG202 (gene therapy injection)
What this could lead to
If successful, this one-time gene therapy could reduce or eliminate the need for frequent eye injections for wet AMD, helping maintain vision with less hassle.
What could go wrong
This is an early phase I/II trial with only 60 participants, so safety and effectiveness are not yet proven. 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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2032

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. Male or female, aged ≥50 years old; 2. The study eye must be diagnosed of wAMD and current active lesions; 3. Subjects have clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis; 4. Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans; 5. Subjects are Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; subjects have good compliance and are willing to abide by the research procedures. Exclusion Criteria: 1. The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection ; 2. The study eye has a history of retinal detachment or retinal detachment during the screening period; 3. The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD; 4. Any intraocular surgery is planned for the study eye during the study period; 5. The study eye currently has retinal angiomatous proliferation (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome; 6. Presence of glaucoma or optic neuropathy that involves or compromises the central visual field of the study eye or presence of uncontrolled high intraocular pressure in the study eye; 7. The fellow eye meets the definition of legal blindness; 8. Hormone-induced increased intraocular pressure in any eye; 9. Active infection in any eye this trial (such as those who cannot understand and comply with the trial requirements or are deemed unsuitable for safety reasons).

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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.

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