Recruiting
Phase 3

Active-Controlled Trial

Sponsor:

4D Molecular Therapeutics

Code:

NCT07064759

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

4D-150 IVT (3E10 vg/eye)

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Study Details

Brief summary:

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

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Study ID

NCT07064759

Start date

Jul 22, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4D-150 IVT (3E10 vg/eye)

active comparator: Aflibercept (AFLB) 2 mg IVT

Interventions

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

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Eylea (aflibercept) will be administered at applicable visits

Primary outcome measure

  • Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52 [ Time Frame: 52 Weeks ]

Central Contacts and Locations

Central contacts

4DMT Patient Advocacy

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

Locations

Research Network Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

Principal Investigator:

Mark Barakat, MD

Barnet Dulaney Perkins Eye Center

Recruiting

Sun City, Arizona, United States, 85351

Principal Investigator:

Suhail Alam, MD

Retina Associates

Recruiting

Tucson, Arizona, United States, 85704

Principal Investigator:

Cameron Javid, MD

Retinal Diagnostic Center

Recruiting

Campbell, California, United States, 95008

Principal Investigator:

Amr Dessouki, MD

Retina Consultants of Orange County

Recruiting

Fullerton, California, United States, 92835

Principal Investigator:

Ashkan Pirouz, MD

Northern California Retina Vitreous Associates

Recruiting

Mountain View, California, United States, 94040

Principal Investigator:

Mark Wieland, MD

Retinal Consultants Medical Group Inc.

Recruiting

Sacramento, California, United States, 95825

Principal Investigator:

Joel Pearlman, MD, PhD

Retinal Consultants Medical Group

Recruiting

Sacramento, California, United States, 95841

Principal Investigator:

Margaret Chang, MD

West Coast Retina Medical Group

Recruiting

San Francisco, California, United States, 94109

Principal Investigator:

Michael Jumper, MD

Bay Area Retina Associates

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Subhransu Ray, MD, PhD

Retina Consultants of Southern Colorado P.C.

Recruiting

Colorado Springs, Colorado, United States, 80909

Principal Investigator:

Standford Taylor, MD

Southwest Retina Consultants

Recruiting

Durango, Colorado, United States, 81303

Principal Investigator:

Sara Haug, MD, PHD

ClearVista Clinical Research

Recruiting

Hudson, Florida, United States, 34667

Principal Investigator:

Dana Deupree, MD, FASRS

Florida Retina Institute

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Matthew Cunningham, MD, PhD

Retina Specialty Institute

Recruiting

Pensacola, Florida, United States, 32503

Principal Investigator:

Sunil Gupta, MD

Retina Vitreous Associates of Florida

Recruiting

St. Petersburg, Florida, United States, 33711

Principal Investigator:

David Eichenbaum, MD, FASRS

East Florida Eye Institute

Recruiting

Stuart, Florida, United States, 34994

Principal Investigator:

Ronald Frenkel, MD

Retina Vitreous Associates of Florida

Recruiting

Tampa, Florida, United States, 33617

Principal Investigator:

Ashley Crane, MD

Thomas Eye Group

Recruiting

Sandy Springs, Georgia, United States, 30328

Principal Investigator:

Paul Kaufman, MD

Retina Associates, Ltd.

Recruiting

Elmhurst, Illinois, United States, 60126

Principal Investigator:

Aaron Weinberg, MD

University Retina and Macula Associates, PC

Recruiting

Oak Forest, Illinois, United States, 60452

Principal Investigator:

Veeral Sheth, MD, MBA, FACS, FASRS

Illinois Retina Associates

Recruiting

Oak Park, Illinois, United States, 60304

Principal Investigator:

Mathew MacCumber, MD, PhD

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62703

Principal Investigator:

Ramanath Bhandari, MD

Retina Partners Midwest, PC

Recruiting

Carmel, Indiana, United States, 46032

Principal Investigator:

Raj Maturi, MD, FASRS

The Retina Care Center

Recruiting

Baltimore, Maryland, United States, 21209

Principal Investigator:

Matthew Speicher, MD

Cumberland Valley Retina Consultants

Recruiting

Hagerstown, Maryland, United States, 21740

Principal Investigator:

Allen Hu, MD

Mid Atlantic Retina Specialist

Recruiting

Hagerstown, Maryland, United States, 21740

Principal Investigator:

Adam Gerstenblith, MD

New England Retina Consultants

Recruiting

Springfield, Massachusetts, United States, 01107

Principal Investigator:

David Lally, MD

Foundation for Vision Research

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Thomas Aaberg, MD

Sierra Eye Associates

Recruiting

Reno, Nevada, United States, 89502

Principal Investigator:

Arshad Khanani, MD, MA, FASRS

Envision Ocular, LLC

Recruiting

Bloomfield, New Jersey, United States, 07003

Principal Investigator:

Patrick Higgins, MD

Retina Vitreous Surgeons of CNY PC

Recruiting

Liverpool, New York, United States, 13088

Principal Investigator:

Jamin Brown, MD

New York Presbyterian Hospital - Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Tongalp Tezel, MD

Vitreoretinal Consultants of NY

Recruiting

Westbury, New York, United States, 11590

Principal Investigator:

James Lin, MD

North Carolina Retina Associates

Recruiting

Cary, North Carolina, United States, 27511

Principal Investigator:

Rebecca Manning, MD

North Carolina Retina Associates

Recruiting

Wake Forest, North Carolina, United States, 27587

Principal Investigator:

John Thordsen, MD

Cincinnati Eye Institute

Recruiting

Cincinnati, Ohio, United States, 45242

Principal Investigator:

Robert Sisk, MD, FACS, FASRS

Verum Research, LLC

Recruiting

Eugene, Oregon, United States, 947401

Principal Investigator:

Albert Edwards, MD, PhD, MBA

EyeHealth Northwest

Recruiting

Portland, Oregon, United States, 97233

Principal Investigator:

Brian Chan-Kai, MD

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16505

Principal Investigator:

David Almeida, MD, MBA, PhD, DABO, FRCSC, FAS

Charleston Neuroscience Institute, LLC

Recruiting

Bluffton, South Carolina, United States, 29910

Principal Investigator:

Mona Camacci, MD, MS

Carolina Eyecare

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Principal Investigator:

Jonathan Brugger, MD

Palmetto Retina Center

Recruiting

West Columbia, South Carolina, United States, 29169

Principal Investigator:

Stephen Hypes, DO

Black Hills Regional Eye Institute

Recruiting

Rapid City, South Dakota, United States, 57701

Principal Investigator:

Prema Abraham, MD

Tennessee Retina, PC

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Carl Awh, MD, FASRS

Southwest Retina Specialist - Panhandle Eye group, LLP

Recruiting

Amarillo, Texas, United States, 79106

Principal Investigator:

Jason Edward Ysasaga, MD

Austin Clinical Research

Recruiting

Austin, Texas, United States, 78750

Principal Investigator:

Fuad Makkouk, MD

Texas Retina Associate

Recruiting

Dallas, Texas, United States, 75231

Principal Investigator:

Ashkan Abbey, MD, FASRS, FAAO

Tyler Retina Consultants

Recruiting

Tyler, Texas, United States, 75703

Principal Investigator:

Samuel Minaker, MD

Strategic Clinical Research

Recruiting

Willow Park, Texas, United States, 76087

Principal Investigator:

Seong Young Lee, MD

Rocky Mountain Retina Consultants

Recruiting

Salt Lake City, Utah, United States, 84107

Principal Investigator:

Mitchell Goff, MD

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

Principal Investigator:

Golnaz Javey, MD

Pacific Northwest Retina

Recruiting

Silverdale, Washington, United States, 98383

Principal Investigator:

Todd Schneiderman, MD, FASRS

Eye Clinic of Wisconsin

Recruiting

Wausau, Wisconsin, United States, 54403

Principal Investigator:

Deepak Sambhara, MD, FASRS

More Information

Sponsor

4D Molecular Therapeutics

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • 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
  • nAMD
  • Retinal gene therapy
  • Intravitreal gene therapy
  • Genetic Medicine
  • Ocular Gene Therapy
  • Gene Therapy
  • 4FRONT
  • 4FRONT-2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 4D Molecular Therapeutics on 2026-04-16.