Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a One-Time gene therapy offer lasting protection for diabetic retinopathy?

NCT ID NCT05296447

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is a long-term follow-up for people who previously received an injection of RGX-314, a gene therapy, for diabetic retinopathy (with or without diabetic macular edema). The purpose is to monitor the safety and effectiveness of the treatment over a total of five years after the injection. Participants will be observed for any eye-related or other side effects, and the study will track changes in the severity of diabetic retinopathy. The goal is to see if this one-time treatment can provide lasting benefit and reduce the need for ongoing eye injections.

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, a gene therapy injected into the suprachoroidal space of the eye
What this could lead to
If successful, this could lead to a long-lasting, one-time treatment for diabetic retinopathy, potentially reducing the need for frequent eye injections.
What could go wrong
This is a Phase 2 follow-up study, so the treatment is still experimental. Long-term safety and effectiveness are not yet established, and there may be unknown risks or side effects.

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 100 people

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

Started

Apr 2022

Expected to finish

Jun 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: * Must provide written, signed informed consent for this study * Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study * Must be willing and able to comply with all study procedures Exclusion Criteria: * None

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Center involved diabetic macular edema are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diabetic macular edema diabetic retinopathy

As listed by the trial registrant

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

Diabetic retinopathy (DR)

How to take part

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

  1. The places running it

    20 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

  • Austin Clinical Research

    Austin, Texas, 78750, United States

  • California Eye Specialists Medical Group, Inc

    Pasadena, California, 91107, United States

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • California Retina Consultants CRC

    Santa Barbara, California, 93103, United States

  • Charles Retina Institute, P.C

    Germantown, Tennessee, 38138, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107, United States

  • New Jersey Retina

    Teaneck, New Jersey, 07666, 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 Diagnostic Center

    Los Angeles, California, 90017, United States

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014, United States

  • Sierra eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center, PC

    Augusta, Georgia, 30909, United States

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

More trials for these conditions

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