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

NCT ID NCT04567550

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 2 times

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.

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

139 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Dec 2026

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

25 to 89 years

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.

Part 1 (DR without CI-DME): Inclusion Criteria: * Patients 25-89 years of age with a diabetic retinopathy (DR) diagnosis of nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months * HbA1c \< 12%. * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better). * Prior history of CI-DME in the study eye is acceptable. * Must be willing and able to provide written, signed informed consent. Exclusion Criteria: * Neovascularization in the study eye from a cause other than DR. * Presence of any active CI-DME. * Active or history of retinal detachment in the study eye. * Any evidence or documented history of PRP or retinal laser in the study eye. * Patients who had a prior vitrectomy surgery. * Women of childbearing potential. Part 2 (DR with CI-DME): Inclusion Criteria: * Patients 25-89 years of age with diabetic retinopathy secondary to diabetes mellitus Type 1 or 2. * HbA1c \< 12% * Macular thickening secondary to DME involving the center of the fovea, CST on SD-OCT (≥ 325 μm) * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of 78-25 letters (approximate Snellen equivalent of 20/32 to 20/320) * Participants must have demonstrated a meaningful response to anti-VEGF therapy. * Must be willing and able to provide written, signed informed consent Exclusion Criteria: * Neovascularization in the study eye from a cause other than DR. * Active or history of retinal detachment in the study eye. * Any evidence or documented history of PRP or retinal laser in the study eye. * Patients who had a prior vitrectomy surgery. * Women of childbearing potential. Note: Other inclusions/exclusions criteria apply.

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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.

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

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