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RECRUITING

NCT07064759

PHASE3

Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Sponsor: 4D Molecular Therapeutics

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2025-07-22

Completion Date

2029-02

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

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

BIOLOGICAL

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

Eylea (aflibercept) will be administered at applicable visits

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

Locations (43)

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, United States

Retina Associates

Tucson, Arizona, United States

Retinal Diagnostic Center

Campbell, California, United States

Retina Consultants of Orange County

Fullerton, California, United States

West Coast Retina Medical Group

San Francisco, California, United States

Southwest Retina Consultants

Durango, Colorado, United States

ClearVista Clinical Research

Hudson, Florida, United States

Retina Vitreous Associates of Florida

Tampa, Florida, United States

Thomas Eye Group

Sandy Springs, Georgia, United States

The Retina Care Center

Baltimore, Maryland, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Mid Atlantic Retina Specialist

Hagerstown, Maryland, United States

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, United States

Vitreoretinal Consultants of NY

Westbury, New York, United States

North Carolina Retina Associates

Cary, North Carolina, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Verum Research, LLC

Eugene, Oregon, United States

Charleston Neuroscience Institute, LLC

Bluffton, South Carolina, United States

Carolina Eyecare

Mt. Pleasant, South Carolina, United States

Tennessee Retina, PC

Nashville, Tennessee, United States

Southwest Retina Specialist - Panhandle Eye group, LLP

Amarillo, Texas, United States

Texas Retina Associate

Dallas, Texas, United States

Tyler Retina Consultants

Tyler, Texas, United States

Rocky Mountain Retina Consultants

Salt Lake City, Utah, United States

Pacific Northwest Retina

Silverdale, Washington, United States

Charles Research Center

Buenos Aires, Argentina

Zora Eye Hospital

Sofia, Bulgaria

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, Germany

Budapest Retina Associates

Budapest, Hungary

Semmelweis Egyetem - Szemészeti Klinika

Budapest, Hungary

DE KK Ophthalmology Clinic

Debrecen, Hungary

Ganglion Medical Center

Pécs, Hungary

SzTE SZAKK Szemeszeti Klinika

Szeged, Hungary

Hayashi Eye Hospital

Fukuoka, Japan

P.Stradins University Hospital

Riga, Latvia

Riga East University hospital

Riga, Latvia

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Aibili - Cec

Coimbra, Portugal

Singapore Eye Research Institute (SERI)

Singapore, Singapore

Tan Tock Seng Hospital TTSH

Singapore, Singapore

Clinica Bonanova de Cirugía Ocular

Barcelona, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

The Retina Clinic London

London, United Kingdom