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Purpose

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

Condition

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

ArmDescriptionAssigned Intervention
Experimental
4D-150 IVT (3E10 vg/eye)
  • Biological: 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
Active Comparator
Aflibercept (AFLB) 2 mg IVT
  • Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)
    Eylea (aflibercept) will be administered at applicable visits

Recruiting Locations

Research Network Arizona
Scottsdale, Arizona 85255

Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351

Retina Associates
Tucson, Arizona 85704

Retinal Diagnostic Center
Campbell, California 95008

Retina Consultants of Orange County
Fullerton, California 92835

Northern California Retina Vitreous Associates
Mountain View, California 94040

Retinal Consultants Medical Group Inc.
Sacramento, California 95825

Retinal Consultants Medical Group
Sacramento, California 95841

West Coast Retina Medical Group
San Francisco, California 94109

Bay Area Retina Associates
Walnut Creek, California 94598

Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado 80909

Southwest Retina Consultants
Durango, Colorado 81303

ClearVista Clinical Research
Hudson, Florida 34667

Florida Retina Institute
Orlando, Florida 32806

Retina Specialty Institute
Pensacola, Florida 32503

Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711

East Florida Eye Institute
Stuart, Florida 34994

Retina Vitreous Associates of Florida
Tampa, Florida 33617

Thomas Eye Group
Sandy Springs, Georgia 30328

Retina Associates, Ltd.
Elmhurst, Illinois 60126

University Retina and Macula Associates, PC
Oak Forest, Illinois 60452

Illinois Retina Associates
Oak Park, Illinois 60304

Springfield Clinic
Springfield, Illinois 62703

Retina Partners Midwest, PC
Carmel, Indiana 46032

The Retina Care Center
Baltimore, Maryland 21209

Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740

Mid Atlantic Retina Specialist
Hagerstown, Maryland 21740

New England Retina Consultants
Springfield, Massachusetts 01107

Foundation for Vision Research
Grand Rapids, Michigan 49546

Sierra Eye Associates
Reno, Nevada 89502

Envision Ocular, LLC
Bloomfield, New Jersey 07003

Retina Vitreous Surgeons of CNY PC
Liverpool, New York 13088

New York Presbyterian Hospital - Columbia University Medical Center
New York, New York 10032

Vitreoretinal Consultants of NY
Westbury, New York 11590

North Carolina Retina Associates
Cary, North Carolina 27511

North Carolina Retina Associates
Wake Forest, North Carolina 27587

Cincinnati Eye Institute
Cincinnati, Ohio 45242

Verum Research, LLC
Eugene, Oregon 947401

EyeHealth Northwest
Portland, Oregon 97233

Erie Retina Research
Erie, Pennsylvania 16505

Charleston Neuroscience Institute, LLC
Bluffton, South Carolina 29910

Carolina Eyecare
Mt. Pleasant, South Carolina 29464

Palmetto Retina Center
West Columbia, South Carolina 29169

Black Hills Regional Eye Institute
Rapid City, South Dakota 57701

Tennessee Retina, PC
Nashville, Tennessee 37203

Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas 79106

Austin Clinical Research
Austin, Texas 78750

Texas Retina Associate
Dallas, Texas 75231

Tyler Retina Consultants
Tyler, Texas 75703

Strategic Clinical Research
Willow Park, Texas 76087

Rocky Mountain Retina Consultants
Salt Lake City, Utah 84107

Piedmont Eye Center
Lynchburg, Virginia 24502

Pacific Northwest Retina
Silverdale, Washington 98383

Eye Clinic of Wisconsin
Wausau, Wisconsin 54403

More Details

Status
Recruiting
Sponsor
4D Molecular Therapeutics

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.