Back to Trials
NCT07064759PHASE3Recruiting

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

4D Molecular Therapeutics

Start Date

7/22/2025

Completion Date

2/1/2029

Summary

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

Eligibility Criteria

Age Range: 50 years to No maximum

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

Interventions

BIOLOGICAL

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

BIOLOGICAL

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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Locations

Research Network Arizona

Scottsdale, Arizona 85255

United States

Barnet Dulaney Perkins Eye Center

Sun City, Arizona 85351

United States

Retina Associates

Tucson, Arizona 85704

United States

Retinal Diagnostic Center

Campbell, California 95008

United States

Retina Consultants of Orange County

Fullerton, California 92835

United States

Northern California Retina Vitreous Associates

Mountain View, California 94040

United States

Retinal Consultants Medical Group Inc.

Sacramento, California 95825

United States

Retinal Consultants Medical Group

Sacramento, California 95841

United States

West Coast Retina Medical Group

San Francisco, California 94109

United States

Bay Area Retina Associates

Walnut Creek, California 94598

United States

Retina Consultants of Southern Colorado P.C.

Colorado Springs, Colorado 80909

United States

Southwest Retina Consultants

Durango, Colorado 81303

United States

ClearVista Clinical Research

Hudson, Florida 34667

United States

Florida Retina Institute

Orlando, Florida 32806

United States

Retina Specialty Institute

Pensacola, Florida 32503

United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida 33711

United States

East Florida Eye Institute

Stuart, Florida 34994

United States

Retina Vitreous Associates of Florida

Tampa, Florida 33617

United States

Thomas Eye Group

Sandy Springs, Georgia 30328

United States

Retina Associates, Ltd.

Elmhurst, Illinois 60126

United States

University Retina and Macula Associates, PC

Oak Forest, Illinois 60452

United States

Illinois Retina Associates

Oak Park, Illinois 60304

United States

Springfield Clinic

Springfield, Illinois 62703

United States

Retina Partners Midwest, PC

Carmel, Indiana 46032

United States

The Retina Care Center

Baltimore, Maryland 21209

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland 21740

United States

Mid Atlantic Retina Specialist

Hagerstown, Maryland 21740

United States

New England Retina Consultants

Springfield, Massachusetts 01107

United States

Foundation for Vision Research

Grand Rapids, Michigan 49546

United States

Sierra Eye Associates

Reno, Nevada 89502

United States

Envision Ocular, LLC

Bloomfield, New Jersey 07003

United States

Retina Vitreous Surgeons of CNY PC

Liverpool, New York 13088

United States

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York 10032

United States

Vitreoretinal Consultants of NY

Westbury, New York 11590

United States

North Carolina Retina Associates

Cary, North Carolina 27511

United States

North Carolina Retina Associates

Wake Forest, North Carolina 27587

United States

Cincinnati Eye Institute

Cincinnati, Ohio 45242

United States

Verum Research, LLC

Eugene, Oregon 947401

United States

EyeHealth Northwest

Portland, Oregon 97233

United States

Erie Retina Research

Erie, Pennsylvania 16505

United States

Charleston Neuroscience Institute, LLC

Bluffton, South Carolina 29910

United States

Carolina Eyecare

Mt. Pleasant, South Carolina 29464

United States

Palmetto Retina Center

West Columbia, South Carolina 29169

United States

Black Hills Regional Eye Institute

Rapid City, South Dakota 57701

United States

Tennessee Retina, PC

Nashville, Tennessee 37203

United States

Southwest Retina Specialist - Panhandle Eye group, LLP

Amarillo, Texas 79106

United States

Austin Clinical Research

Austin, Texas 78750

United States

Texas Retina Associate

Dallas, Texas 75231

United States

Tyler Retina Consultants

Tyler, Texas 75703

United States

Strategic Clinical Research

Willow Park, Texas 76087

United States

Rocky Mountain Retina Consultants

Salt Lake City, Utah 84107

United States

Piedmont Eye Center

Lynchburg, Virginia 24502

United States

Pacific Northwest Retina

Silverdale, Washington 98383

United States

Eye Clinic of Wisconsin

Wausau, Wisconsin 54403

United States

Grupo Láser Visión

Rosario, Santa Fe Province 2000

Argentina

Microcirugia Ocular Rosario

Rosario, Santa Fe Province 2000

Argentina

Centro Privado de Ojos

Buenos Aires, 1033

Argentina

Charles Research Center

Buenos Aires, 1116

Argentina

OFTALMOS

Buenos Aires, 1830

Argentina

Centrovisión

Mendoza, 5500

Argentina

Adelaide Eye and Retina Centre

Adelaide, SA 5000

Australia

Eye Clinic Albury Wodonga

Albury, NSW 2640

Australia

Strathfield Retina Clinic

Strathfield, NSW 2135

Australia

Sydney Retina Clinic and Day Surgery

Sydney, NSW 2000

Australia

Zora Eye Hospital

Sofia,

Bulgaria

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf,

Germany

Augenzentrum Frankfurt

Frankfurt, 60549

Germany

Dietrich Bonhoeffer Klinikum

Neubrandenburg, 17036

Germany

Bajcsy-Zsilinszky Kórház

Budapest, 1106

Hungary

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

AOU delle Marche

Ancona, 60126

Italy

Kozawa Eye Hospital and Diabetes Center

Mito, Ibaraki 310-0845

Japan

University of the Ryukyus Hospital

Ginowan, Okinawa 901-2725

Japan

Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital

Fukuoka, 811-0213

Japan

Hayashi Eye Hospital

Fukuoka,

Japan

National Hospital Organization Tokyo Medical Center

Tokyo, 152-8902

Japan

P.Stradins University Hospital

Riga,

Latvia

Riga East University hospital

Riga,

Latvia

Ziemekurzemes Regionala Slimnica

Ventspils,

Latvia

Hospital of Lithuanian University of Health Sciences

Kaunas, LT-50161

Lithuania

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

Miranza Instituto Gomez-Ulla

Santiago de Compostela, Spain 15706

Spain

Clinica Bonanova de Cirugía Ocular

Barcelona,

Spain

Hospital Universitario Virgen Macarena

Seville,

Spain

Bradford Royal Infirmary

Bradford, UK BD9 6TB

United Kingdom

The Retina Clinic London

London,

United Kingdom

Sunderland Eye Infirmary

Sunderland, SR2 9HP

United Kingdom