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

NCT ID NCT05296447

ENROLLING_BY_INVITATION Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

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.

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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

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

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