Gene therapy shot could end need for repeated eye needles in diabetes

NCT ID NCT04567550

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

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests RGX-314, a gene therapy given as a single injection into the eye, for people with diabetic retinopathy. The goal is to see if it can improve vision and reduce the need for frequent anti-VEGF injections. About 139 adults with diabetes-related eye damage are participating.

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 gene therapy (a single injection into the eye that produces anti-VEGF protein)
What this could lead to: If successful, this could offer a one-time treatment for diabetic retinopathy, reducing or eliminating the need for repeated eye injections.
What could go wrong: This is a phase 2 trial with only 139 participants, so results are preliminary. The therapy may not work for everyone, and there are risks from the injection and steroid use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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 (CI-DME) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

CENTER-INVOLVED DIABETIC MACULAR EDEMA (CI-DME) DIABETIC RETINOPATHY, DR

Contacts and locations

Locations

Austin Clinical Research, LLC

Austin, Texas, 78750, United States
Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, 85016, United States
California Eye Specialists Medical Group, Inc

Pasadena, California, 91107, United States
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
Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States
Duke University Eye Center

Durham, North Carolina, 27705, United States
Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States
NJ 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 Research Institute of Texas, LLC

Abilene, Texas, 79606, United States
Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90017, United States
Retinal Consultants San Diego

Poway, California, 92064, United States
Retinal Consultants of Texas

The Woodlands, Texas, 77384, United States
Retinal Diagnostic Center

Campbell, California, 95008, 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
Springfield Clinic

Springfield, Illinois, 62702, United States
Star Retina

Burleson, Texas, 76028, 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
Wilmer Eye Institute/Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

More trials for these conditions

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