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Gene therapy shot could end monthly eye injections for wet AMD

NCT ID NCT04514653

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a gene therapy called RGX-314 for wet age-related macular degeneration (AMD), a leading cause of vision loss. The treatment is given as one or two injections into the eye and aims to produce proteins that block abnormal blood vessel growth, potentially replacing the need for frequent anti-VEGF injections. About 146 participants who have responded well to standard therapy will be randomly assigned to receive different doses of RGX-314 or the standard drug ranibizumab. The main goal is to see if RGX-314 can maintain or improve vision at 40 weeks compared to monthly ranibizumab 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 gene therapy (a one-time injection into the eye that produces anti-VEGF proteins)
What this could lead to
If successful, this could offer a one-time treatment for wet AMD, reducing or eliminating the need for frequent eye injections.
What could go wrong
This is a Phase 2 trial with a small number of participants. The gene therapy may not work as well as current injections, and there are risks like inflammation or infection from the procedure.

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

146 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Feb 2027

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

50 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.

Inclusion Criteria: * Age \>/= 50 and \</= 89 * Diagnosis of CNV secondary to age-related macular degeneration in the study eye. * Participants must have demonstrated a meaningful response to anti-VEGF therapy. * Willing and able to provide written, signed informed consent for this study. Exclusion Criteria: * CNV or macular edema in the study eye secondary to any causes other than AMD. * Subfoveal fibrosis or atrophy in study eye. * Participants who have had a prior vitrectomy. * Active or history of retinal detachment in the study eye. * History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry. * Received any gene therapy. * Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract. * History of intraocular surgery in the study eye within 12 weeks of study entry. * Receipt of any IP within 30 days of study entry or 5 half-lives of the IP. * Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry. * Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye. COHORT 6 AND 7 ONLY: * Active or history of glaucoma or ocular hypertension (steroid-induced ocular hypertension (Cohort 7 only)) in the study eye. * Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1. Note: Other inclusion/exclusion criteria apply.

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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)

Contacts and locations

Locations

  • California Retina Consultants - Bakersfield /ID# 255910

    Bakersfield, California, 93309-1677, United States

  • California Retina Consultants - Santa Barbara /ID# 255923

    Santa Barbara, California, 93103, United States

  • Charles Retina Institute /ID# 255922

    Germantown, Tennessee, 38138, United States

  • Duke University Medical Center /ID# 267646

    Durham, North Carolina, 27710, United States

  • Eye Associates of New Mexico /ID# 255915

    Albuquerque, New Mexico, 87109, United States

  • Johns Hopkins Hospital /ID# 255919

    Baltimore, Maryland, 21287, United States

  • Mid Atlantic Retina /ID# 255906

    Philadelphia, Pennsylvania, 19107, United States

  • Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920

    Mountain View, California, 94040-4101, United States

  • Ophthalmic Consultants of Boston /ID# 255917

    Boston, Massachusetts, 02114, United States

  • Retina Consultants - The Woodlands /ID# 255924

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of San Diego /ID# 255911

    Poway, California, 92064-2530, United States

  • Retina Vitreous Assoc Med Grp /ID# 255921

    Beverly Hills, California, 90211, United States

  • Retinal Diagnostic Center /ID# 272275

    Campbell, California, 95008, United States

  • Retinal Research Institute /ID# 255925

    Phoenix, Arizona, 85053, United States

  • Sierra Eye Associates /ID# 255908

    Reno, Nevada, 89502, United States

  • Southeast Retina Center /ID# 255912

    Augusta, Georgia, 30909, United States

  • Springfield Clinic - First /ID# 272274

    Springfield, Illinois, 62702, United States

  • Tennessee Retina - Nashville /ID# 255918

    Nashville, Tennessee, 37203-1513, United States

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