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One shot to save sight? gene therapy trial aims to end frequent eye injections for wet AMD

NCT ID NCT07064759

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, a gene therapy, in 480 adults with wet age-related macular degeneration (AMD). The goal is to see if one treatment can maintain or improve vision and reduce the need for standard anti-VEGF injections like Eylea. Participants will be followed for up to two years.

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 (a gene therapy given as a single eye injection)
What this could lead to
If successful, this could mean people with wet AMD need far fewer eye injections, possibly just one treatment lasting years instead of regular shots.
What could go wrong
This is still an early Phase 3 trial, so results are not guaranteed. The gene therapy may not work for everyone, and there could be side effects like inflammation or vision changes.

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

Jul 2025

Expected to finish

Feb 2029

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 * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator * 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 Ocular Treatments/Interventions: * Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye 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.

Neovascular age-related macular degeneration (NAMD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    94 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Adelaide Eye and Retina Centre

    RECRUITING

    Adelaide, SA 5000, Australia

  • Aibili - Cec

    RECRUITING

    Coimbra, Portugal

  • Augenzentrum Frankfurt

    RECRUITING

    Frankfurt, 60549, Germany

  • Austin Clinical Research

    RECRUITING

    Austin, Texas, 78750, United States

  • Bajcsy-Zsilinszky Kórház

    RECRUITING

    Budapest, 1106, Hungary

  • Barnet Dulaney Perkins Eye Center

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Bay Area Retina Associates

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Black Hills Regional Eye Institute

    RECRUITING

    Rapid City, South Dakota, 57701, United States

  • Bradford Royal Infirmary

    RECRUITING

    Bradford, UK, BD9 6TB, United Kingdom

  • Budapest Retina Associates

    RECRUITING

    Budapest, Hungary

  • Carolina Eyecare

    RECRUITING

    Mt. Pleasant, South Carolina, 29464, United States

  • Centro Privado de Ojos

    RECRUITING

    Buenos Aires, 1033, Argentina

  • Centrovisión

    RECRUITING

    Mendoza, 5500, Argentina

  • Charles Research Center

    RECRUITING

    Buenos Aires, 1116, Argentina

  • Charleston Neuroscience Institute, LLC

    RECRUITING

    Bluffton, South Carolina, 29910, United States

  • Cincinnati Eye Institute

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • ClearVista Clinical Research

    RECRUITING

    Hudson, Florida, 34667, United States

  • Clinica Bonanova de Cirugía Ocular

    RECRUITING

    Barcelona, Spain

  • Cumberland Valley Retina Consultants

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • DE KK Ophthalmology Clinic

    RECRUITING

    Debrecen, Hungary

  • Dietrich Bonhoeffer Klinikum

    RECRUITING

    Neubrandenburg, 17036, Germany

  • East Florida Eye Institute

    RECRUITING

    Stuart, Florida, 34994, United States

  • Envision Ocular, LLC

    RECRUITING

    Bloomfield, New Jersey, 07003, United States

  • Erie Retina Research

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Eye Clinic Albury Wodonga

    RECRUITING

    Albury, NSW 2640, Australia

  • Eye Clinic of Wisconsin

    RECRUITING

    Wausau, Wisconsin, 54403, United States

  • EyeHealth Northwest

    RECRUITING

    Portland, Oregon, 97233, United States

  • Florida Retina Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Foundation for Vision Research

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Ganglion Medical Center

    RECRUITING

    Pécs, Hungary

  • Grupo Láser Visión

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Hayashi Eye Hospital

    RECRUITING

    Fukuoka, Japan

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Spain

  • Hospital of Lithuanian University of Health Sciences

    RECRUITING

    Kaunas, LT-50161, Lithuania

  • Illinois Retina Associates

    RECRUITING

    Oak Park, Illinois, 60304, United States

  • Internationale Innovative Ophthalmochirurgie GbR

    RECRUITING

    Düsseldorf, Germany

  • Kozawa Eye Hospital and Diabetes Center

    RECRUITING

    Mito, Ibaraki, 310-0845, Japan

  • Microcirugia Ocular Rosario

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Mid Atlantic Retina Specialist

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Miranza Instituto Gomez-Ulla

    RECRUITING

    Santiago de Compostela, Spain, 15706, Spain

  • National Hospital Organization Tokyo Medical Center

    RECRUITING

    Tokyo, 152-8902, Japan

  • New England Retina Consultants

    RECRUITING

    Springfield, Massachusetts, 01107, United States

  • New York Presbyterian Hospital - Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • North Carolina Retina Associates

    RECRUITING

    Cary, North Carolina, 27511, United States

  • North Carolina Retina Associates

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Northern California Retina Vitreous Associates

    RECRUITING

    Mountain View, California, 94040, United States

  • OFTALMOS

    RECRUITING

    Buenos Aires, 1830, Argentina

  • P.Stradins University Hospital

    RECRUITING

    Riga, Latvia

  • Pacific Northwest Retina

    RECRUITING

    Silverdale, Washington, 98383, United States

  • Palmetto Retina Center

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Piedmont Eye Center

    RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Research Network Arizona

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Retina Associates

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Retina Associates, Ltd.

    RECRUITING

    Elmhurst, Illinois, 60126, United States

  • Retina Consultants of Orange County

    RECRUITING

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern Colorado P.C.

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • Retina Partners Midwest, PC

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Retina Specialty Institute

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    Tampa, Florida, 33617, United States

  • Retina Vitreous Surgeons of CNY PC

    RECRUITING

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group

    RECRUITING

    Sacramento, California, 95841, United States

  • Retinal Consultants Medical Group Inc.

    RECRUITING

    Sacramento, California, 95825, United States

  • Retinal Diagnostic Center

    RECRUITING

    Campbell, California, 95008, United States

  • Riga East University hospital

    RECRUITING

    Riga, Latvia

  • Rocky Mountain Retina Consultants

    RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Semmelweis Egyetem - Szemészeti Klinika

    RECRUITING

    Budapest, Hungary

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502, United States

  • Singapore Eye Research Institute (SERI)

    RECRUITING

    Singapore, Singapore

  • Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital

    RECRUITING

    Fukuoka, 811-0213, Japan

  • Southwest Retina Consultants

    RECRUITING

    Durango, Colorado, 81303, United States

  • Southwest Retina Specialist - Panhandle Eye group, LLP

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62703, United States

  • Strategic Clinical Research

    RECRUITING

    Willow Park, Texas, 76087, United States

  • Strathfield Retina Clinic

    RECRUITING

    Strathfield, NSW 2135, Australia

  • Sunderland Eye Infirmary

    RECRUITING

    Sunderland, SR2 9HP, United Kingdom

  • Sydney Retina Clinic and Day Surgery

    RECRUITING

    Sydney, NSW 2000, Australia

  • SzTE SZAKK Szemeszeti Klinika

    RECRUITING

    Szeged, Hungary

  • Tan Tock Seng Hospital TTSH

    RECRUITING

    Singapore, Singapore

  • Tennessee Retina, PC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associate

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Retina Care Center

    RECRUITING

    Baltimore, Maryland, 21209, United States

  • The Retina Clinic London

    RECRUITING

    London, United Kingdom

  • Thomas Eye Group

    RECRUITING

    Sandy Springs, Georgia, 30328, United States

  • Tyler Retina Consultants

    RECRUITING

    Tyler, Texas, 75703, United States

  • University Retina and Macula Associates, PC

    RECRUITING

    Oak Forest, Illinois, 60452, United States

  • University of the Ryukyus Hospital

    RECRUITING

    Ginowan, Okinawa, 901-2725, Japan

  • Verum Research, LLC

    RECRUITING

    Eugene, Oregon, 947401, United States

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania

  • Vitreoretinal Consultants of NY

    RECRUITING

    Westbury, New York, 11590, United States

  • West Coast Retina Medical Group

    RECRUITING

    San Francisco, California, 94109, United States

  • Ziemekurzemes Regionala Slimnica

    RECRUITING

    Ventspils, Latvia

  • Zora Eye Hospital

    RECRUITING

    Sofia, Bulgaria

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