Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Purpose
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Condition
- Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥50 years of age at time of consent - MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator - 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
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 Ocular Treatments/Interventions: - Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 4D-150 IVT (3E10 vg/eye) |
|
|
|
Active Comparator Aflibercept (AFLB) 2 mg IVT |
|
Recruiting Locations
Research Network Arizona
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351
Sun City, Arizona 85351
Retina Associates
Tucson, Arizona 85704
Tucson, Arizona 85704
Retinal Diagnostic Center
Campbell, California 95008
Campbell, California 95008
Retina Consultants of Orange County
Fullerton, California 92835
Fullerton, California 92835
Northern California Retina Vitreous Associates
Mountain View, California 94040
Mountain View, California 94040
Retinal Consultants Medical Group Inc.
Sacramento, California 95825
Sacramento, California 95825
Retinal Consultants Medical Group
Sacramento, California 95841
Sacramento, California 95841
West Coast Retina Medical Group
San Francisco, California 94109
San Francisco, California 94109
Bay Area Retina Associates
Walnut Creek, California 94598
Walnut Creek, California 94598
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Southwest Retina Consultants
Durango, Colorado 81303
Durango, Colorado 81303
ClearVista Clinical Research
Hudson, Florida 34667
Hudson, Florida 34667
Florida Retina Institute
Orlando, Florida 32806
Orlando, Florida 32806
Retina Specialty Institute
Pensacola, Florida 32503
Pensacola, Florida 32503
Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711
St. Petersburg, Florida 33711
East Florida Eye Institute
Stuart, Florida 34994
Stuart, Florida 34994
Retina Vitreous Associates of Florida
Tampa, Florida 33617
Tampa, Florida 33617
Thomas Eye Group
Sandy Springs, Georgia 30328
Sandy Springs, Georgia 30328
Retina Associates, Ltd.
Elmhurst, Illinois 60126
Elmhurst, Illinois 60126
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
Oak Forest, Illinois 60452
Illinois Retina Associates
Oak Park, Illinois 60304
Oak Park, Illinois 60304
Springfield Clinic
Springfield, Illinois 62703
Springfield, Illinois 62703
Retina Partners Midwest, PC
Carmel, Indiana 46032
Carmel, Indiana 46032
The Retina Care Center
Baltimore, Maryland 21209
Baltimore, Maryland 21209
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Mid Atlantic Retina Specialist
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
New England Retina Consultants
Springfield, Massachusetts 01107
Springfield, Massachusetts 01107
Foundation for Vision Research
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Sierra Eye Associates
Reno, Nevada 89502
Reno, Nevada 89502
Envision Ocular, LLC
Bloomfield, New Jersey 07003
Bloomfield, New Jersey 07003
Retina Vitreous Surgeons of CNY PC
Liverpool, New York 13088
Liverpool, New York 13088
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Vitreoretinal Consultants of NY
Westbury, New York 11590
Westbury, New York 11590
North Carolina Retina Associates
Cary, North Carolina 27511
Cary, North Carolina 27511
North Carolina Retina Associates
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
Cincinnati Eye Institute
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Verum Research, LLC
Eugene, Oregon 947401
Eugene, Oregon 947401
EyeHealth Northwest
Portland, Oregon 97233
Portland, Oregon 97233
Erie Retina Research
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Carolina Eyecare
Mt. Pleasant, South Carolina 29464
Mt. Pleasant, South Carolina 29464
Palmetto Retina Center
West Columbia, South Carolina 29169
West Columbia, South Carolina 29169
Black Hills Regional Eye Institute
Rapid City, South Dakota 57701
Rapid City, South Dakota 57701
Tennessee Retina, PC
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas 79106
Amarillo, Texas 79106
Austin Clinical Research
Austin, Texas 78750
Austin, Texas 78750
Texas Retina Associate
Dallas, Texas 75231
Dallas, Texas 75231
Tyler Retina Consultants
Tyler, Texas 75703
Tyler, Texas 75703
Strategic Clinical Research
Willow Park, Texas 76087
Willow Park, Texas 76087
Rocky Mountain Retina Consultants
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Piedmont Eye Center
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
Pacific Northwest Retina
Silverdale, Washington 98383
Silverdale, Washington 98383
Eye Clinic of Wisconsin
Wausau, Wisconsin 54403
Wausau, Wisconsin 54403
More Details
- Status
- Recruiting
- Sponsor
- 4D Molecular Therapeutics