RECRUITING

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

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Conditions

Macular Neovascularization Secondary to Age-Related Macular DegenerationAge-related macular degenerationAMDExudative AMDNeovascular AMDExudative age-related macular degenerationNeovascular age-related macular degenerationWet age-related macular degenerationWet macular degenerationWet AMDwAMDRetinal gene therapyIntravitreal gene therapyGenetic MedicineOcular Gene TherapynAMD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-03
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06864988

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥50 years of age at time of consent
  2. * Treatment naïve MNV secondary to nAMD in the study eye
  3. * 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
  4. * Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
  5. * BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
  1. * MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter))
  2. * History of retinal detachment in the study eye
  3. * History of or presence of active inflammation in either eye
  4. * Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
  5. * Major illness or major surgical procedure in the 28 days prior to the Screening Visit
  6. * Uncontrolled blood pressure
  7. * Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
  8. * History of autoimmune condition that may predispose to the development of uveitis

Contacts and Locations

Study Contact

4DMT Patient Advocacy
CONTACT
(888) 748-8881
clinicaltrials@4DMT.com

Principal Investigator

Hersh Patel
STUDY_DIRECTOR
4D Molecular Therapeutics

Study Locations (Sites)

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
Gavin Herbert Eye Institute
Orange, California, 92868
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
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
RSC Research, LLC
Denver, Colorado, 80210
United States
Connecticut Eye Consultants
Danbury, Connecticut, 06810
United States
New England Retina Associates (NERA)
Hamden, Connecticut, 06518
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
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
Bascom Palmer Eye Institute Palm Beach Gardens
Palm Beach Gardens, Florida, 33418
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Retina Vitreous Associates of Florida
Saint Petersburg, Florida, 33711
United States
Retina Associates of Sarasota
Sarasota, Florida, 34232
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
Midwest Eye Institute
Carmel, Indiana, 46290
United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509
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
Saint 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
Retina Associates of Cleveland
Cleveland, Ohio, 44130
United States
Cole Eye Institute
Cleveland, Ohio, 44195
United States
Retina Associates of Cleveland
Cleveland, Ohio, 44505
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
Charles Retina Institute Germantown
Germantown, Tennessee, 38138
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 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

Collaborators and Investigators

Sponsor: 4D Molecular Therapeutics

  • Hersh Patel, STUDY_DIRECTOR, 4D Molecular Therapeutics

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 Registration Dates

Study Start Date2025-03-03
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Age-related macular degeneration
  • AMD
  • Exudative AMD
  • Neovascular AMD
  • Exudative age-related macular degeneration
  • Neovascular age-related macular degeneration
  • Wet age-related macular degeneration
  • Wet macular degeneration
  • Wet AMD
  • wAMD
  • Retinal gene therapy
  • Intravitreal gene therapy
  • Genetic Medicine
  • Ocular Gene Therapy
  • nAMD

Additional Relevant MeSH Terms

  • Macular Neovascularization Secondary to Age-Related Macular Degeneration