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

Last updated: March 4, 2025
Sponsor: 4D Molecular Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetic Retinopathy

Macular Degeneration

Geographic Atrophy

Treatment

4D-150 IVT (3E10 vg/eye)

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Clinical Study ID

NCT06864988
4D-150-C003
  • Ages > 50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 hyperreflectivematerial, or leakage) identified by fluorescein angiography (FA) or spectral domainoptical coherence tomography (SD-OCT), in the study eye, at the Screening Visitconfirmed by the Reading Center

  • Demonstrated clinical response to aflibercept and functional stability in the studyeye as confirmed by the Reading Center

  • BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) inthe study eye at the Screening Visit

Exclusion

Exclusion Criteria:

Ocular Conditions:

  • MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinalhemorrhage 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 forcontrol

Systemic Conditions and Considerations:

  • Major illness or major surgical procedure in the 28 days prior to the ScreeningVisit

  • Uncontrolled blood pressure

  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization,cerebrovascular accident, transient ischemic attack within 6 months of the ScreeningVisit

  • History of autoimmune condition that may predispose to the development of uveitis

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: 4D-150 IVT (3E10 vg/eye)
Phase: 3
Study Start date:
March 03, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Calgary Retina Consultants

    Calgary, Alberta T2H 0C8
    Canada

    Site Not Available

  • St. Michaels Hospital

    North York, Ontario M5B 1W8
    Canada

    Site Not Available

  • Retina Institute of Ottawa, Inc.

    Ottawa, Ontario K2B 7E9
    Canada

    Site Not Available

  • Krembil Neuroscience Centre

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Emanuelli Research & Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Retinal Research Institute, LLC

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • The Retina Partners

    Encino, California 91436
    United States

    Site Not Available

  • Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Loma Linda University Faculty Medical Clinics

    Loma Linda, California 92354
    United States

    Site Not Available

  • Jules Stein Eye Institute

    Los Angeles, California 90095
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates

    Mountain View, California 94040
    United States

    Site Not Available

  • Gavin Herbert Eye Institute

    Orange, California 92868
    United States

    Site Not Available

  • Retina Consultants of San Diego

    Poway, California 92064
    United States

    Site Not Available

  • Kaiser Permanente-Riverside Medical Center

    Riverside, California 92505
    United States

    Site Not Available

  • Retinal Consultants Medical Group Inc

    Sacramento, California 95825
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • California Retina Consultants - Santa Barbara

    Santa Barbara, California 93103
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • University of Colorado, Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • RSC Research, LLC

    Denver, Colorado 80210
    United States

    Site Not Available

  • Connecticut Eye Consultants

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • New England Retina Associates (NERA)

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Vitreo Retinal Associates

    Gainesville, Florida 34481
    United States

    Site Not Available

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Bascom Palmer Eye Institute Palm Beach Gardens

    Palm Beach Gardens, Florida 33418
    United States

    Site Not Available

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Retina Associates of Sarasota

    Sarasota, Florida 34232
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart, Florida 34994
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Georgia Retina PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Retina Consultants of Hawaii

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Retina Associates - Elmhurst

    Elmhurst, Illinois 60126
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Midwest Eye Institute

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Retina Associates of Kentucky

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Wilmer Eye Institute John's Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Retina Group of Washington

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • MD Medical Research

    Waldorf, Maryland 20745
    United States

    Site Not Available

  • New England Retina Consultants

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Mississippi Retina Associates

    Madison, Mississippi 39110
    United States

    Site Not Available

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • NJ Retina

    Edison, New Jersey 08820
    United States

    Site Not Available

  • NJ Retina

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Eye Associates of New Mexico Vision Research Center

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York 13088
    United States

    Site Not Available

  • Vitreous Retina Macula Consultants of New York

    New York, New York 10022
    United States

    Site Not Available

  • Retina Associates of Western New York

    Rochester, New York 14620
    United States

    Site Not Available

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • North Carolina (NC) Retina Associates

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cole Eye Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Retina Associates of Cleveland

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • EyeHealth Northwest Peterkort

    Portland, Oregon 97225
    United States

    Site Not Available

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • The Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Charleston Neuroscience Center

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Charleston Neuroscience Institute

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Charles Retina Institute Germantown

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Clinical Research

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina & Vitreous of Texas, PLLC

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Consultants of Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Retina Center

    Houston, Texas 77043
    United States

    Site Not Available

  • RCTX - Westover Hills Retina Center

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Retina Associates of South Texas PA

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Texas San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Site Not Available

  • Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Retina Institute of Virginia

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin 54403
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.