Recruiting
Phase 3

ABP 938 vs. Aflibercept

Sponsor:

Amgen

Code:

NCT07614776

Conditions

Neovascular Age-related Macular Degeneration

nAMD

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

ABP 938 8 mg

Aflibercept (US) 8 mg

Study Details

Brief 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)

Conditions

Neovascular Age-related Macular Degeneration

nAMD

Study ID

NCT07614776

Start date

May 27, 2026

Status verified date

Aug, 2026

Completion date

Jan 12, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABP 938 8 mg

Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.

active comparator: Aflibercept (US) 8 mg

Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.

Interventions

ABP 938 8 mg

IVT injection

Aflibercept (US) 8 mg

IVT injection

Primary outcome measure

  • Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: Baseline and Week 12 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Retina Consultants of Orange County

Recruiting

Fullerton, California, United States, 92835-3432

South Coast Retina Center - RCA

Recruiting

Long Beach, California, United States, 90607

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

Recruiting

Modesto, California, United States, 95356

California Eye Specialists Medical Group, Inc

Recruiting

Pasadena, California, United States, 91107

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

Recruiting

Sacramento, California, United States, 95825

California Retina Consultants

Recruiting

Santa Barbara, California, United States, 93103

Retina Consultants of Southern Colorado (Colorado Springs)- RCA

Recruiting

Colorado Springs, Colorado, United States, 80909-1183

Retina Consultants of Southern Colorado (Pueblo)- RCA

Recruiting

Colorado Springs, Colorado, United States, 80909

Colorado Retina Associates (RCA)

Recruiting

Lakewood, Colorado, United States, 80228

Retina Group of New England

Recruiting

Waterford, Connecticut, United States, 06385

Medeye Associates - Research

Recruiting

Miami, Florida, United States, 33143

Retina Consultants of Southwest Florida - Naples

Recruiting

Naples, Florida, United States, 34103-4457

Advanced Research, LLC

Recruiting

Pensacola, Florida, United States, 32503

Retina Associates

Recruiting

Elmhurst, Illinois, United States, 60126

Associated Vitreoretinal and Uveitis Consultants

Recruiting

Carmel, Indiana, United States, 46032

The Retina Care Center- Baltimore (PRISM Vision Group)

Recruiting

Baltimore, Maryland, United States, 21209

Mid Atlantic Retina Specialists

Recruiting

Hagerstown, Maryland, United States, 21740-5846

Retina Specialists

Recruiting

Towson, Maryland, United States, 21204

Ophthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Retina Consultants of Minnesota

Recruiting

Edina, Minnesota, United States, 55435

Mississippi Retina Assoc

Recruiting

Madison, Mississippi, United States, 39110

The Retina Institute, Research Retina Institute (RCA)

Recruiting

St Louis, Missouri, United States, 63128

Envision Ocular, LLC

Recruiting

Bloomfield, New Jersey, United States, 07003

Vision Research Center Eye Associates of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87109

Retina Vitreous Surgeons of CNY, PC

Recruiting

Liverpool, New York, United States, 13088

Ophthalmic Consultants of Long Island - Research

Recruiting

Oceanside, New York, United States, 11572

North Carolina Retina Associates

Recruiting

Raleigh, North Carolina, United States, 27607-7514

NC Retina Associates-RCA

Recruiting

Wake Forest, North Carolina, United States, 27587

Midwest Retina - Main Office

Recruiting

Dublin, Ohio, United States, 43016

Eye Care Specialists - Kingston

Recruiting

Kingston, Pennsylvania, United States, 18704-4801

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

Recruiting

Beaufort, South Carolina, United States, 29902

Charleston Neuroscience Institute

Recruiting

Charleston, South Carolina, United States, 29414-5896

Palmetto Retina Center - Main (RCA)

Recruiting

Columbia, South Carolina, United States, 29169

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

Recruiting

Ladson, South Carolina, United States, 29456

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

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Palmetto Retina Center, Florence (RCA)

Recruiting

West Columbia, South Carolina, United States, 29169

Tennessee Retina PC

Recruiting

Nashville, Tennessee, United States, 37203

Texas Retina Associates (TRA) - Arlington

Recruiting

Arlington, Texas, United States, 76012

Austin Retina Associates - Ophthalmology/Retina

Recruiting

Austin, Texas, United States, 78705

Austin Retina Associates

Recruiting

Austin, Texas, United States, 78705

Retina Consultants of Texas - Bellaire

Recruiting

Bellaire, Texas, United States, 77401

Texas Retina Associates (TRA) - Dallas Main

Recruiting

Dallas, Texas, United States, 75231

Texas Retina Associates - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Retina Consultants of Texas - Katy Retina Center

Recruiting

Houston, Texas, United States, 77401

Retina Consultants of Texas - The Woodlands

Recruiting

Katy, Texas, United States, 77494

Retinal Consultants of Texas- San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Retina Consultants of Texas - Schertz

Recruiting

Schertz, Texas, United States, 78154

Strategic Clinical Research Group, LLC

Recruiting

Willow Park, Texas, United States, 76087

Retina Associates of Utah - Retina Specialist

Recruiting

Salt Lake City, Utah, United States, 84107

Emerson Clinical Research- Virginia Retina Specialists

Recruiting

Falls Church, Virginia, United States, 22042-2349

Vitreoretinal Associates of Washington

Recruiting

Bellevue, Washington, United States, 98004-3779

Retina Center NW PLLC

Recruiting

Silverdale, Washington, United States, 98383

Spokane Eye Clinic (OCT and optical exam

Recruiting

Spokane, Washington, United States, 99204-2509

More Information

Sponsor

Amgen

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • ABP 938
  • Aflibercept
  • neovascular age-related macular degeneration
  • Intravitreal
  • Randomized Controlled Trial
  • Double-masked

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-24.