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RECRUITING

NCT07614776

PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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)

Official title: A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

304

Start Date

2026-05-27

Completion Date

2028-01-12

Last Updated

2026-10-14

Healthy Volunteers

Conditions

Neovascular Age-related Macular Degeneration nAMD

Interventions

DRUG

ABP 938 8 mg

IVT injection

DRUG

Aflibercept (US) 8 mg

IVT injection

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

Locations (81)

Retina Consultants of Orange County

Fullerton, California, United States

South Coast Retina Center - RCA

Long Beach, California, United States

Retinal Consultants Medical Group, Inc - Modesto (RCA)

Modesto, California, United States

California Eye Specialists Medical Group, Inc

Pasadena, California, United States

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

Sacramento, California, United States

California Retina Consultants

Santa Barbara, California, United States

Retina Consultants of Southern Colorado (Colorado Springs)- RCA

Colorado Springs, Colorado, United States

Retina Consultants of Southern Colorado (Pueblo)- RCA

Colorado Springs, Colorado, United States

Colorado Retina Associates (RCA)

Lakewood, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Medeye Associates - Research

Miami, Florida, United States

Retina Consultants of Southwest Florida - Naples

Naples, Florida, United States

Advanced Research, LLC

Pensacola, Florida, United States

University Retina - Bedford Park Location

Chicago, Illinois, United States

Retina Associates

Elmhurst, Illinois, United States

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, United States

The Retina Care Center- Baltimore (PRISM Vision Group)

Baltimore, Maryland, United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Retina Specialists

Towson, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Retina Consultants of Minnesota (RCM) - St. Louis Park

Edina, Minnesota, United States

Mississippi Retina Assoc

Madison, Mississippi, United States

The Retina Institute, Research Retina Institute (RCA)

St Louis, Missouri, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, United States

Ophthalmic Consultants of Long Island - Research

Oceanside, New York, United States

Long Island Vitreoretinal Consultants(RCA Network)

Scarsdale, New York, United States

North Carolina Retina Associates

Raleigh, North Carolina, United States

NC Retina Associates- RCA

Wake Forest, North Carolina, United States

Midwest Retina - Main Office

Dublin, Ohio, United States

Eye Care Specialists - Kingston

Kingston, Pennsylvania, United States

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

Beaufort, South Carolina, United States

Charleston Neuroscience Institute

Charleston, South Carolina, United States

Palmetto Retina Center - Main (RCA)

Columbia, South Carolina, United States

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

Ladson, South Carolina, United States

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

Mt. Pleasant, South Carolina, United States

Palmetto Retina Center, Florence (RCA)

West Columbia, South Carolina, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Texas Retina Associates (TRA) - Arlington

Arlington, Texas, United States

Austin Retina Associates - Ophthalmology/Retina

Austin, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Retina Consultants of Texas - Bellaire

Bellaire, Texas, United States

Texas Retina Associates (TRA) - Dallas Main

Dallas, Texas, United States

Texas Retina Associates - Fort Worth

Fort Worth, Texas, United States

Retina Consultants of Texas - Katy Retina Center

Houston, Texas, United States

Retina Consultants of Texas - The Woodlands

Katy, Texas, United States

Retinal Consultants of Texas- San Antonio

San Antonio, Texas, United States

Retina Consultants of Texas - Schertz

Schertz, Texas, United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Retina Associates of Utah - Retina Specialist

Salt Lake City, Utah, United States

Emerson Clinical Research- Virginia Retina Specialists

Falls Church, Virginia, United States

Vitreoretinal Associates of Washington

Bellevue, Washington, United States

Retina Center NW PLLC

Silverdale, Washington, United States

Spokane Eye Clinic (OCT and optical exam

Spokane, Washington, United States

Visus, spol. s r.o. - Nachod

Náchod, Hradec Králové Region, Czechia

Fakultni nemocnice Ostrava - Ocni klinika

Ostrava - Poruba, Ostrava-město, Czechia

AXON clinical

Prague, Prague, Czechia

Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje - Klaudianova nemocnice

Mladá Boleslav, Stredoceský Kraj, Czechia

FN Kralovske Vinohrady - Oftalmologicka klinika

Prague, Czechia

Debreceni Egyetem OEC - Ophthalmology

Debrecen, Hajdú-Bihar, Hungary

Eszak-pesti Centrumkorhaz - Honvedkorhaz

Budapest, Hungary

SUGITA EYE HOSPITAL - Ophthalmology

Nagoya, Aichi-ken, Japan

Tokyo Medical Center - Ophthalmology

Meguro-ku, Tokyo, Japan

Tokushima University Hospital - Ophthalmology

Ube, Yamaguchi, Japan

Nihon University Hospital - Ophthalmology

Tokyo, Japan

Latvian American Eye Center

Riga, Riga, Latvia

P.Stradina Clinical University Hospital - Ophthalmology

Riga, Latvia

Lietuvos Sveikatos Mokslu Universitetas (LSMU) - Kauno Klinikos - ophthalmology

Kaunas, Kaunas County, Lithuania

OFTALMIKA Sp. z o. o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Szpital sw. Rozy Sp. z o.o.

Krakow, Masovian Voivodeship, Poland

Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.

Olsztyn, Warmian-Masurian Voivodeship, Poland

Univerzitna nemocnica Bratislava - Ocna klinika SZU a UNB

Bratislava, Bratislava Region, Slovakia

NsP Trebisov, a.s. - Ocne oddelenie

Trebišov, Košice Region, Slovakia

FNsP F.D.R. Banska Bystrica - II. Ocna klinika SZU

Banska Bystrica, Trenčín Region, Slovakia

Fakultna nemocnica Trencin - Ocna klinika

Trenčín, Trenčín Region, Slovakia

Fakultna nemocnica s poliklinikou Zilina - Ocne oddelenie

Žilina, Žilina Region, Slovakia

Hospital Universitari General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)

Barcelona, Catalonia, Spain

Clinica Universidad de Navarra - Oftalmología

Navarra, Navarre, Spain

Hospital Provincial De Conxo - Oftalmología

Santiago de Compostela, Sevilla, Spain