4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
NCT ID: NCT06864988
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-03-03
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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4D-150 IVT (3E10 vg/eye)
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
Aflibercept (AFLB) 2 mg IVT
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits
Interventions
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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
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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4D Molecular Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Hersh Patel
Role: STUDY_DIRECTOR
4D Molecular Therapeutics
Locations
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Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Retinal Research Institute, LLC
Scottsdale, Arizona, United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, United States
California Retina Consultants
Bakersfield, California, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Gavin Herbert Eye Institute
Orange, California, United States
Retina Consultants of San Diego
Poway, California, United States
Kaiser Permanente-Riverside Medical Center
Riverside, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants - Santa Barbara
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
RSC Research, LLC
Denver, Colorado, United States
Connecticut Eye Consultants
Danbury, Connecticut, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Vitreo Retinal Associates
Gainesville, Florida, United States
Florida Retina Institute - Jacksonville
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Associates of Sarasota
Sarasota, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Retina Associates - Elmhurst
Elmhurst, Illinois, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Haik Humble Eye Center
West Monroe, Louisiana, United States
Maine Eye Center
Portland, Maine, United States
Wilmer Eye Institute John's Hopkins University
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, United States
MD Medical Research
Waldorf, Maryland, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Mississippi Retina Associates
Madison, Mississippi, United States
Deep Blue Retina Clinical Research
Southaven, Mississippi, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
NJ Retina
Edison, New Jersey, United States
NJ Retina
Teaneck, New Jersey, United States
Eye Associates of New Mexico Vision Research Center
Albuquerque, New Mexico, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, United States
Vitreous Retina Macula Consultants of New York
New York, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
North Carolina (NC) Retina Associates
Wake Forest, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Piedmont Retina Specialists - Winston Salem Office
Winston-Salem, North Carolina, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Cole Eye Institute
Cleveland, Ohio, United States
Retina Vitreous Center
Edmond, Oklahoma, United States
Verum Research, LLC
Eugene, Oregon, United States
EyeHealth Northwest Peterkort
Portland, Oregon, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Erie Retina Research
Erie, Pennsylvania, United States
The Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Center
Charleston, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research
Austin, Texas, United States
Retina & Vitreous of Texas, PLLC
Bellaire, Texas, United States
Retina Consultants of Houston
Bellaire, Texas, United States
Texas Retina Center
Houston, Texas, United States
Retina Associates of South Texas PA
San Antonio, Texas, United States
Retina Consultants of Texas San Antonio
San Antonio, Texas, United States
RCTX - Westover Hills Retina Center
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Group of Washington
Fairfax, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Calgary Retina Consultants
Calgary, Alberta, Canada
Retina Surgical Associates
New Westminster, British Columbia, Canada
St. Michaels Hospital
North York, Ontario, Canada
Retina Institute of Ottawa, Inc.
Ottawa, Ontario, Canada
Krembil Neuroscience Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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4D-150-C003
Identifier Type: -
Identifier Source: org_study_id
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