4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
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
1 other identifier
interventional
480
2 countries
100
Brief Summary
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
Typical duration for phase_3
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2025
CompletedFirst Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 25, 2026
March 1, 2026
2.2 years
March 4, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in BCVA ETDRS letter score at Week 52
52 Weeks
Secondary Outcomes (5)
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
104 Weeks
Mean change from baseline in CST over time through Weeks 52 and 104
104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
104 Weeks
Study Arms (2)
4D-150 IVT (3E10 vg/eye)
EXPERIMENTALAflibercept (AFLB) 2 mg IVT
ACTIVE COMPARATORInterventions
Eylea (aflibercept) will be administered at applicable visits
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
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016, United States
Retinal Research Institute, LLC
Scottsdale, Arizona, 85254, United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, 72764, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
The Retina Partners
Encino, California, 91436, United States
Retina Associates of Southern California
Huntington Beach, California, 92647, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, 92354, United States
Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retina Consultants of San Diego
Poway, California, 92064, United States
Kaiser Permanente-Riverside Medical Center
Riverside, California, 92505, United States
Retinal Consultants Medical Group Inc
Sacramento, California, 95825, United States
Retinal Consultants Medical Group Inc
Sacramento, California, 95840, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants - Santa Barbara
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
University of Colorado, Denver
Aurora, Colorado, 80045, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
RSC Research, LLC
Denver, Colorado, 80210, United States
Connecticut Eye Consultants
Danbury, Connecticut, 06810, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Vitreo Retinal Associates
Gainesville, Florida, 34481, United States
Florida Retina Institute - Jacksonville
Jacksonville, Florida, 32216, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Associates of Sarasota
Sarasota, Florida, 34232, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
University of Chicago
Chicago, Illinois, 60637, United States
Retina Associates - Elmhurst
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates, PC
Lemont, Illinois, 60439, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Midwest Eye Institute
Carmel, Indiana, 46290, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Haik Humble Eye Center
West Monroe, Louisiana, 71291, United States
Maine Eye Center
Portland, Maine, 04101, United States
Wilmer Eye Institute John's Hopkins University
Baltimore, Maryland, 21287, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, 21740, United States
MD Medical Research
Waldorf, Maryland, 20745, United States
New England Retina Consultants
Springfield, Massachusetts, 01107, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
Deep Blue Retina Clinical Research
Southaven, Mississippi, 38671, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
NJ Retina
Edison, New Jersey, 08820, United States
NJ Retina
Teaneck, New Jersey, 07666, United States
Eye Associates of New Mexico Vision Research Center
Albuquerque, New Mexico, 87109, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, 13088, United States
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803, United States
Duke Eye Center
Durham, North Carolina, 27705, United States
North Carolina (NC) Retina Associates
Wake Forest, North Carolina, 27587, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Piedmont Retina Specialists - Winston Salem Office
Winston-Salem, North Carolina, 27157, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44122, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44130, United States
Cole Eye Institute
Cleveland, Ohio, 44195, United States
Retina Vitreous Center
Edmond, Oklahoma, 73013, United States
Verum Research, LLC
Eugene, Oregon, 97401, United States
EyeHealth Northwest Peterkort
Portland, Oregon, 97225, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
The Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Charleston Neuroscience Center
Charleston, South Carolina, 29414, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates
Knoxville, Tennessee, 37763, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Research Center for Retina
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Retina & Vitreous of Texas, PLLC
Bellaire, Texas, 77401, United States
Retina Consultants of Houston
Bellaire, Texas, 77401, United States
Texas Retina Center
Houston, Texas, 77043, United States
Retina Associates of South Texas PA
San Antonio, Texas, 78240, United States
Retina Consultants of Texas San Antonio
San Antonio, Texas, 78240, United States
RCTX - Westover Hills Retina Center
San Antonio, Texas, 78251, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Group of Washington
Fairfax, Virginia, 22031, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403, United States
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8, Canada
Retina Surgical Associates
New Westminster, British Columbia, V3L 5H1, Canada
St. Michaels Hospital
North York, Ontario, M5B 1W8, Canada
Retina Institute of Ottawa, Inc.
Ottawa, Ontario, K2B 7E9, Canada
Krembil Neuroscience Centre
Toronto, Ontario, M5T 2S8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hersh Patel
4D Molecular Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 7, 2025
Study Start
March 3, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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).