4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
- Conditions
- Macular Neovascularization Secondary to Age-Related Macular Degeneration
- Interventions
- Biological: 4D-150 IVT (3E10 vg/eye)
- Registration Number
- NCT06864988
- Lead Sponsor
- 4D Molecular Therapeutics
- Brief Summary
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- ≥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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4D-150 IVT (3E10 vg/eye) 4D-150 IVT (3E10 vg/eye) - Aflibercept (AFLB) 2 mg IVT EYLEA® (aflibercept) Injection 2 mg (0.05mL) -
- Primary Outcome Measures
Name Time Method Mean change from baseline in BCVA ETDRS letter score at Week 52 52 Weeks
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (91)
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
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
RSC Research, LLC
🇺🇸Denver, Colorado, United States
Connecticut Eye Consultants
🇺🇸Danbury, Connecticut, United States
New England Retina Associates (NERA)
🇺🇸Hamden, 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 Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Retina Associates of Sarasota
🇺🇸Sarasota, 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
Midwest Eye Institute
🇺🇸Carmel, Indiana, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Wilmer Eye Institute John's Hopkins University
🇺🇸Baltimore, Maryland, United States
Retina Group of Washington
🇺🇸Fairfax, Virginia, 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
Mississippi Retina Associates
🇺🇸Madison, Mississippi, United States
Deep Blue Retina Clinical Research
🇺🇸Southaven, Mississippi, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Envision Ocular, LLC
🇺🇸Bloomfield, 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
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
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 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
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
St. Michaels Hospital
🇨🇦North York, Ontario, Canada
Retina Institute of Ottawa, Inc.
🇨🇦Ottawa, Ontario, Canada
Krembil Neuroscience Centre
🇨🇦Toronto, Ontario, Canada
Emanuelli Research & Development Center LLC
🇵🇷Arecibo, Puerto Rico