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One shot to save sight? gene therapy aims to cut eye injections for wet AMD

NCT ID NCT06864988

Disease control Sponsor: 4D Molecular Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests a single injection of 4D-150 gene therapy in 480 adults with wet age-related macular degeneration (AMD). The goal is to see if one treatment can control the disease as well as or better than standard aflibercept injections given every few weeks. Participants will be followed for two years to compare vision changes and how many additional injections are needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
4D-150 (gene therapy) given as a single injection into the eye
What this could lead to
If successful, this could mean people with wet AMD need far fewer eye injections over time, reducing treatment burden.
What could go wrong
This is still an experimental therapy; it may not work as well as current standard injections, and there could be unknown side effects from the gene therapy.
Why investors are watching

4D Molecular Therapeutics is running a Phase 3 trial of its gene therapy 4D-150 for a common cause of severe vision loss in older adults. The trial compares a single injection of 4D-150 against an active control in 480 participants. For a small company, this late-stage readout is a central test of whether its lead product works and can reach the market.

If it works: A positive result could position 4D-150 as a one-time treatment option that reduces the need for repeated eye injections. That outcome might support regulatory approval and make the therapy a major commercial asset for the company.

If it fails: Phase 3 trials often fail, and a negative or unclear result could delay or end the program. For a small company with few other products, such a setback would likely hurt its prospects significantly.

AI-written from the trial record. Speculative, and not investment advice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

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

Started

Mar 2025

Expected to finish

Jun 2028

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 years and older

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: * ≥50 years of age at time of consent * Treatment naïve MNV secondary to nAMD in the study eye * Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT), in the study eye, at the Screening Visit confirmed by the Reading Center * Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center * BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit * CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center Exclusion Criteria: Ocular Conditions: * MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)) * History of retinal detachment in the study eye * History of or presence of active inflammation in either eye * Glaucoma or intraocular hypertension requiring more than 2 topical medications for control Systemic Conditions and Considerations: * Major illness or major surgical procedure in the 28 days prior to the Screening Visit * Uncontrolled blood pressure * Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit * History of autoimmune condition that may predispose to the development of uveitis

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Conditions

The condition(s) this trial relates to.

macular degeneration wet macular degeneration

As listed by the trial registrant

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

Macular neovascularization secondary to age-related macular degeneration

Contacts and locations

Locations

  • Austin Clinical Research

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona, 85016, United States

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701, United States

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8, Canada

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • California Retina Consultants - Santa Barbara

    Santa Barbara, California, 93103, United States

  • Charleston Neuroscience Center

    Charleston, South Carolina, 29414, United States

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456, United States

  • Cole Eye Institute

    Cleveland, Ohio, 44195, United States

  • Connecticut Eye Consultants

    Danbury, Connecticut, 06810, United States

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740, United States

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi, 38671, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Eye Associates of New Mexico Vision Research Center

    Albuquerque, New Mexico, 87109, United States

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403, United States

  • EyeHealth Northwest Peterkort

    Portland, Oregon, 97225, United States

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Florida Retina Institute

    Orlando, Florida, 32806, United States

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida, 32216, United States

  • Georgia Retina PC

    Marietta, Georgia, 30060, United States

  • Haik Humble Eye Center

    West Monroe, Louisiana, 71291, United States

  • Illinois Retina Associates

    Oak Park, Illinois, 60304, United States

  • Kaiser Permanente-Riverside Medical Center

    Riverside, California, 92505, United States

  • MD Medical Research

    Waldorf, Maryland, 20745, United States

  • Maine Eye Center

    Portland, Maine, 04101, United States

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017, United States

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740, United States

  • Midwest Eye Institute

    Carmel, Indiana, 46290, United States

  • Mississippi Retina Associates

    Madison, Mississippi, 39110, United States

  • NJ Retina

    Edison, New Jersey, 08820, United States

  • NJ Retina

    Teaneck, New Jersey, 07666, United States

  • New England Retina Consultants

    Springfield, Massachusetts, 01107, United States

  • North Carolina (NC) Retina Associates

    Wake Forest, North Carolina, 27587, United States

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040, United States

  • Orange County Retina Medical Group

    Santa Ana, California, 92705, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Piedmont Retina Specialists - Winston Salem Office

    Winston-Salem, North Carolina, 27157, United States

  • RCTX - Westover Hills Retina Center

    San Antonio, Texas, 78251, United States

  • RSC Research, LLC

    Denver, Colorado, 80210, United States

  • Retina & Vitreous of Texas, PLLC

    Bellaire, Texas, 77401, United States

  • Retina Associates - Elmhurst

    Elmhurst, Illinois, 60126, United States

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44122, United States

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130, United States

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509, United States

  • Retina Associates of Sarasota

    Sarasota, Florida, 34232, United States

  • Retina Associates of South Texas PA

    San Antonio, Texas, 78240, United States

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Associates of Western New York

    Rochester, New York, 14620, United States

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Houston

    Bellaire, Texas, 77401, United States

  • Retina Consultants of San Diego

    Poway, California, 92064, United States

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Texas San Antonio

    San Antonio, Texas, 78240, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of Washington, Chevy Chase

    Chevy Chase, Maryland, 20815, United States

  • Retina Group of Washington, Fairfax

    Fairfax, Virginia, 22031, United States

  • Retina Institute of Ottawa, Inc.

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Institute of Virginia

    Richmond, Virginia, 23235, United States

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas, 72764, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialty Institute

    Pensacola, Florida, 32503, United States

  • Retina Surgical Associates

    New Westminster, British Columbia, V3L 5H1, Canada

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013, United States

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825, United States

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95840, United States

  • Retinal Research Institute, LLC

    Scottsdale, Arizona, 85254, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37763, United States

  • Springfield Clinic

    Springfield, Illinois, 62703, United States

  • St. Michaels Hospital

    North York, Ontario, M5B 1W8, Canada

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Texas Retina Associates

    Arlington, Texas, 76012, United States

  • Texas Retina Center

    Houston, Texas, 77043, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • The Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104, United States

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

  • Verum Research, LLC

    Eugene, Oregon, 97401, United States

  • Vitreo Retinal Associates

    Gainesville, Florida, 34481, United States

  • Vitreous Retina Macula Consultants of New York

    New York, New York, 10022, United States

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803, United States