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Can a One-Time gene therapy tame wet AMD for years?

NCT ID NCT05210803

Disease control Sponsor: AbbVie 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 This study
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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study follows people who previously received an experimental gene therapy called RGX-314 for wet age-related macular degeneration (AMD), a leading cause of vision loss. The goal is to see how safe and effective the treatment remains over up to five years after the injection. Participants are monitored for eye and overall health issues, as well as changes in vision. The findings could help determine if RGX-314 offers a durable, long-term option for managing this chronic eye disease.

What this could mean

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

Active substance
RGX-314, an experimental gene therapy delivered via suprachoroidal injection
What this could lead to
If successful, this could support RGX-314 as a long-lasting treatment for wet AMD, potentially reducing the need for frequent eye injections.
What could go wrong
This is a follow-up study, not a new treatment test, and long-term safety and efficacy are still unproven. Possible risks include eye inflammation or other adverse events.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 116 people

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

Started

Dec 2021

Expected to finish

Jul 2031

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Must provide written, signed informed consent for this study. 2. Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study. 3. Must be willing and able to comply with all study procedures. Exclusion Criteria: 1\. None

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

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

Neovascular age-related macular degeneration (NAMD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • California Retina Consultants

    Santa Barbara, California, 93103, United States

  • Charles Retina Institute, P.C

    Germantown, Tennessee, 38138, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Northern California Retina Vitreous Associates Medical Group Inc

    Mountain View, California, 94040, United States

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Retina Consultants San Diego

    Poway, California, 92064, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014, United States

  • Retinovitreous Associates, LTD

    Philadelphia, Pennsylvania, 19107, United States

  • Sierra eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center PC

    Augusta, Georgia, 30909, United States

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Vitreoretinal Surgery PLLC

    Edina, Minnesota, 55435, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.