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NCT07614776PHASE3Recruiting

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Amgen

Start Date

5/27/2026

Completion Date

1/12/2028

Summary

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

Eligibility Criteria

Age Range: 50 years to No maximum

Inclusion Criteria: * Men or women ≥ 50 years old, capable of giving signed informed consent * Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) * Total area of CNV (including both classic and occult components) \> 50% of the total lesion area in the SE * The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE * Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol: * Total lesion size \> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye * Scar, fibrosis, or atrophy involving the central subfield in the study eye * Scar or fibrosis involving \> 50% of the total lesion in the study eye * Presence of retinal pigment epithelium tears or rips involving the macula in the study eye * History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study * Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study * Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye * History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye * Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization * Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening * Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins * History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation * Other protocol-specified exclusion criteria

Interventions

DRUG

ABP 938 8 mg

DRUG

Aflibercept (US) 8 mg

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Conditions

Neovascular Age-related Macular DegenerationnAMD

Locations

Retina Consultants of Orange County

Fullerton, California 92835-3432

United States

South Coast Retina Center - RCA

Long Beach, California 90607

United States

Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)

Modesto, California 95356

United States

California Eye Specialists Medical Group, Inc

Pasadena, California 91107

United States

Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)

Sacramento, California 95825

United States

California Retina Consultants

Santa Barbara, California 93103

United States

Retina Consultants of Southern Colorado (Colorado Springs)- RCA

Colorado Springs, Colorado 80909-1183

United States

Retina Group of New England

Waterford, Connecticut 06385

United States

Medeye Associates - Research

Miami, Florida 33143

United States

Retina Consultants of Southwest Florida - Naples

Naples, Florida 34103-4457

United States

Advanced Research, LLC

Pensacola, Florida 32503

United States

Retina Associates

Elmhurst, Illinois 60126

United States

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana 46032

United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland 21740-5846

United States

Retina Specialists

Towson, Maryland 21204

United States

Retina Consultants of Minnesota

Edina, Minnesota 55435

United States

Mississippi Retina Assoc

Madison, Mississippi 39110

United States

The Retina Institute, Research Retina Institute (RCA)

St Louis, Missouri 63128

United States

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico 87109

United States

Ophthalmic Consultants of Long Island - Research

Oceanside, New York 11572

United States

NC Retina Associates-RCA

Wake Forest, North Carolina 27587

United States

Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)

Beaufort, South Carolina 29902

United States

Charleston Neuroscience Institute

Charleston, South Carolina 29414-5896

United States

Palmetto Retina Center - Main (RCA)

Columbia, South Carolina 29169

United States

Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)

Ladson, South Carolina 29456

United States

Palmetto Retina Center, Florence (RCA)

West Columbia, South Carolina 29169

United States

Texas Retina Associates (TRA) - Arlington

Arlington, Texas 76012

United States

Austin Retina Associates - Ophthalmology/Retina

Austin, Texas 78705

United States

Texas Retina Associates (TRA) - Dallas Main

Dallas, Texas 75231

United States

Texas Retina Associates - Fort Worth

Fort Worth, Texas 76104

United States

Retina Consultants of Texas - Katy Retina Center

Houston, Texas 77401

United States

Retina Consultants of Texas - Schertz

Schertz, Texas 78154

United States

Retina Associates of Utah - Retina Specialist

Salt Lake City, Utah 84107

United States

Emerson Clinical Research- Virginia Retina Specialists

Falls Church, Virginia 22042-2349

United States

Vitreoretinal Associates of Washington

Bellevue, Washington 98004-3779

United States

Retina Center NW PLLC

Silverdale, Washington 98383

United States