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One-Time gene shot could cut eye injections for wet AMD

NCT ID NCT05197270

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study tests a gene therapy called 4D-150 for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The goal is to see if a single injection into the eye can safely reduce the need for regular anti-VEGF shots. About 215 adults aged 50 and older who currently need ongoing eye injections will participate.

Why investors are watching

4D Molecular Therapeutics is testing 4D-150, a gene therapy injected into the eye, to see if it can control wet age-related macular degeneration with fewer anti-VEGF injections. For a small company, this mid-stage trial is a key test of whether its lead product works safely and durably. The result will shape the company's value and its ability to advance the drug.

If it works: If the trial shows 4D-150 reduces the need for regular eye injections while keeping vision stable, the company could have a strong candidate for a large patient population. That could attract partners or funding to move the drug toward later-stage testing.

If it fails: Gene therapy trials often fail on safety or effectiveness, and this one is still early. A poor result or a delay could set the program back and hurt the company's prospects, since it has few other products in late-stage development.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 215 people

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

Started

Dec 2021

Expected to finish

Jan 2031

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.

* 50 years of age Individuals eligible to participate in the trial must meet the following inclusion criteria: 1. ≥50 years of age 2. Diagnosed with CNV secondary to AMD (confirmed by reading center) 3. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye: 4. Central subfield thickness (CST) and/or presence of subretinal or intraretinal fluid requiring continued anti-VEGF therapy in the study eye, as assessed by SD-OCT; and confirmed by a reading center): 5. Study eye amenable to IVT injection 6. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures 7. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye AND has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening: Note: Day -7 aflibercept will be administered ≥ 4 weeks from last IVT anti-VEGF 8. Subjects receiving 4D-150 agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Medical records available to document history of anti-VEGF therapy (dates, drugs, and dosage) for a minimum of 12 months prior to Screening 10. Provide written informed consent. Contralateral Eye Sub-study-Specific Criteria: 1. Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Substudy Screening Visit NOTE: Subjects who received 4D-150 in study eye-1 as part of the Shedding Substudy are also eligible to participate in the Contralateral Eye Substudy only after biological samples from all matrices were at or below the limit of quantitation for vector genomes in at least 3 consecutive measurements AND at least 6 months has passed since 4D-150 administration to study eye-1. 2. Macular neovascularization (MNV) secondary to AMD in study eye-2 as assessed on historical images at any time by SD-OCT (required) and FA when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by the reading center) 3. History of at least 1 anti-VEGF injection in study eye-2 within 6 months prior to Screening (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time point prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 4. BCVA between 25 and 83 ETDRS letters, inclusive (20/320 20/25 Snellen) in study eye-2 5. Study eye-2 amenable to IVT injection 6. BCVA ≥34 ETDRS letters (\~20/200) in the previously treated study eye-1 7. Ability to comply with protocol-specified procedures and visits, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to study eye-2 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent. Shedding Substudy-specific Inclusion Criteria: 1. ≥50 years of age 2. Diagnosed with MNV secondary to AMD as assessed on historical images at any time by spectral domain optical coherence tomography (SD-OCT) (required) and fluorescein angiography when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by Reading Center) 3. Best corrected visual acuity (BCVA) between 10 and 83 ETDRS letters, inclusive (\~20/640 and 20/25, respectively) in the study eye at Screening 4. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye 5. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye; minimum of 1 injection within the last 6 months (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 6. Study eye amenable to IVT injection 7. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent.

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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 (WET) age-related macular degeneration

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

    22 sites in 2 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

  • Austin Clinical Research

    RECRUITING

    Austin, Texas, 78750, United States

  • Barnet Delaney Perkins Eye Center

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • California Retina Consultants

    RECRUITING

    Oxnard, California, 93036, United States

  • Colorado Retina Associates

    RECRUITING

    Lakewood, Colorado, 80288, United States

  • Cumberland Valley Retina Consultants

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Emanuelli Research and Development Center, LLC

    RECRUITING

    Arecibo, 00612, Puerto Rico

  • Florida Eye Associates

    RECRUITING

    Melbourne, Florida, 32901, United States

  • Mid Atlantic Retina

    RECRUITING

    Bethlehem, Pennsylvania, 18017, United States

  • Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Pacific Northwest Retina LLC

    WITHDRAWN

    Bellevue, Washington, 98004, United States

  • Palmetto Retina Center, LLC

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Rand Eye Institute

    SUSPENDED

    Deerfield Beach, Florida, 33064, United States

  • Retina Consultants of Texas

    WITHDRAWN

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Retina Partners Midwest

    RECRUITING

    Carmel, Indiana, 46290, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    Tampa, Florida, 33607, United States

  • Retina Vitreous Consultants, LLP DBA Retina Group of Florida

    ACTIVE_NOT_RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Retinal Consultants Medical Group

    RECRUITING

    Sacramento, California, 95841, United States

  • Retinal Specialty Institute

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502, United States

  • Tennessee Retina

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • University Retina and Macula Associates

    RECRUITING

    Oak Forest, Illinois, 60452, United States

  • Valley Retina Institute, PA

    RECRUITING

    McAllen, Texas, 78503, United States

  • Verum Research, LLC

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Vitreo Retinal Associates

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Western Carolina Retinal Associates

    WITHDRAWN

    Asheville, North Carolina, 28803, United States

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