4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

May 28, 2026 updated by: 4D Molecular Therapeutics

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 5H1
        • Retina Surgical Associates
    • Ontario
      • North York, Ontario, Canada, M5B 1W8
        • St. Michaels Hospital
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Institute of Ottawa, Inc.
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Barnet Dulaney Perkins Eye Center
      • Scottsdale, Arizona, United States, 85254
        • Retinal Research Institute, LLC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Retina Partners of Northwest Arkansas
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Encino, California, United States, 91436
        • The Retina Partners
      • Huntington Beach, California, United States, 92647
        • Retina Associates of Southern California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Poway, California, United States, 92064
        • Retina Consultants of San Diego
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside Medical Center
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group Inc
      • Sacramento, California, United States, 95840
        • Retinal Consultants Medical Group Inc
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants - Santa Barbara
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Denver, Colorado, United States, 80210
        • RSC Research, LLC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Gainesville, Florida, United States, 34481
        • Vitreo Retinal Associates
      • Jacksonville, Florida, United States, 32216
        • Florida Retina Institute - Jacksonville
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Sarasota, Florida, United States, 34232
        • Retina Associates of Sarasota
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates - Elmhurst
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates, PC
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Haik Humble Eye Center
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington, Chevy Chase
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants PC
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists - Hagerstown
      • Waldorf, Maryland, United States, 20745
        • MD Medical Research
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Mississippi Retina Associates
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63128
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
      • Edison, New Jersey, United States, 08820
        • NJ Retina
      • Teaneck, New Jersey, United States, 07666
        • NJ Retina
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Eye Associates of New Mexico Vision Research Center
    • New York
      • Liverpool, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central New York
      • New York, New York, United States, 10022
        • Vitreous Retina Macula Consultants of New York
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
      • Durham, North Carolina, United States, 27705
        • Duke Eye Center
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina (NC) Retina Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Piedmont Retina Specialists - Winston Salem Office
    • Ohio
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44122
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44195
        • Cole Eye Institute
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research, LLC
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest Peterkort
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Mid Atlantic Retina
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
      • Philadelphia, Pennsylvania, United States, 19104
        • The Scheie Eye Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Neuroscience Center
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37763
        • Southeastern Retina Associates
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Houston
      • Bellaire, Texas, United States, 77401
        • Retina & Vitreous of Texas, PLLC
      • Houston, Texas, United States, 77043
        • Texas Retina Center
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas PA
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas San Antonio
      • San Antonio, Texas, United States, 78251
        • RCTX - Westover Hills Retina Center
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Retina Group of Washington, Fairfax
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4D-150 IVT (3E10 vg/eye)
Biological: 4D-150 IVT (3E10 vg/eye)
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
Active Comparator: Aflibercept (AFLB) 2 mg IVT
Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in BCVA ETDRS letter score at Week 52
Time Frame: 52 Weeks
52 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
Time Frame: 104 Weeks
104 Weeks
Mean change from baseline in CST over time through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

4D Molecular Therapeutics

Investigators

  • Study Director: Hersh Patel, 4D Molecular Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4D-150-C003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in AMD in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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