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

  • Macular Neovascularization Secondary to Age-Related Macular Degeneration

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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

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 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

Retinal Research Institute, LLC
Scottsdale, Arizona 85254

Retina Partners of Northwest Arkansas
Springdale, Arkansas 72764

California Retina Consultants
Bakersfield, California 93309

Retina Vitreous Associates Medical Group
Beverly Hills, California 90211

The Retina Partners
Encino, California 91436

Retinal Consultants Medical Group Inc
Sacramento, California 95825

Retinal Consultants Medical Group Inc
Sacramento, California 95840

California Retina Consultants - Santa Barbara
Santa Barbara, California 93103

Bay Area Retina Associates
Walnut Creek, California 94598

RSC Research, LLC
Denver, Colorado 80210

Rand Eye Institute
Deerfield Beach, Florida 33064

Retina Group of Florida
Fort Lauderdale, Florida 33308

Vitreo Retinal Associates
Gainesville, Florida 34481

Florida Retina Institute - Jacksonville
Jacksonville, Florida 32216

Florida Retina Consultants
Lakeland, Florida 33805

Florida Retina Institute
Orlando, Florida 32806

Retina Specialty Institute
Pensacola, Florida 32503

Retina Vitreous Associates of Florida
Saint Petersburg, Florida 33711

Retina Associates of Sarasota
Sarasota, Florida 34232

Southeast Retina Center
Augusta, Georgia 30909

Retina Associates - Elmhurst
Elmhurst, Illinois 60126

University Retina and Macula Associates, PC
Lemont, Illinois 60439

Midwest Eye Institute
Carmel, Indiana 46290

Retina Associates of Kentucky
Lexington, Kentucky 40509

Cumberland Valley Retina Consultants PC
Hagerstown, Maryland 21740

Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland 21740

Mississippi Retina Associates
Madison, Mississippi 39110

Deep Blue Retina Clinical Research
Southaven, Mississippi 38671

The Retina Institute
Saint Louis, Missouri 63128

Sierra Eye Associates
Reno, Nevada 89502

Envision Ocular, LLC
Bloomfield, New Jersey 07003

Retina-Vitreous Surgeons of Central New York
Liverpool, New York 13088

Vitreous Retina Macula Consultants of New York
New York, New York 10022

Western Carolina Retinal Associate PA
Asheville, North Carolina 28803

North Carolina (NC) Retina Associates
Wake Forest, North Carolina 27587

Retina Vitreous Center
Edmond, Oklahoma 73013

Verum Research, LLC
Eugene, Oregon 97401

EyeHealth Northwest Peterkort
Portland, Oregon 97225

Mid Atlantic Retina
Bethlehem, Pennsylvania 18017

Erie Retina Research
Erie, Pennsylvania 16507

Charleston Neuroscience Center
Charleston, South Carolina 29414

Charleston Neuroscience Institute
Ladson, South Carolina 29456

Palmetto Retina Center
West Columbia, South Carolina 29169

Black Hills Regional Eye Institute
Rapid City, South Dakota 57701

Retina Research Institute of Texas
Abilene, Texas 79606

Texas Retina Associates
Arlington, Texas 76012

Austin Clinical Research
Austin, Texas 78750

Retina Consultants of Houston
Bellaire, Texas 77401

Texas Retina Center
Houston, Texas 77043

Retina Consultants of Texas San Antonio
San Antonio, Texas 78240

RCTX - Westover Hills Retina Center
San Antonio, Texas 78251

Retina Consultants of Texas
The Woodlands, Texas 77384

Retina Group of Washington
Fairfax, Virginia 22031

Piedmont Eye Center
Lynchburg, Virginia 24502

Eye Clinic of Wisconsin
Wausau, Wisconsin 54403

More Details

NCT ID
NCT06864988
Status
Recruiting
Sponsor
4D Molecular Therapeutics

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center