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

NCT07614776 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202501152025-523500-72-00
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 18

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

  Baseline and Week 12

Secondary Outcomes (17)

• Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT)

  Week 16

• Change from Baseline in BCVA as measured by ETDRS letter score

  Baseline to Week 48

• Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24

  Baseline to Week 24

• Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48

  Baseline to Week 48

• Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)

  Baseline to Week 48

Study Arms (2)

ABP 938 8 mg

EXPERIMENTAL

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.

Drug: ABP 938 8 mg

Aflibercept (US) 8 mg

ACTIVE COMPARATOR

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.

Drug: Aflibercept (US) 8 mg

Interventions

ABP 938 8 mg DRUG

IVT injection

ABP 938 8 mg

Aflibercept (US) 8 mg DRUG

IVT injection

Also known as: EYLEA HD

Aflibercept (US) 8 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (18)

South Coast Retina Center - RCA

Long Beach, California, 90607, United States

RECRUITING

California Eye Specialists Medical Group, Inc

Pasadena, California, 91107, United States

RECRUITING

Retina Consultants of San Diego

Poway, California, 92064, United States

RECRUITING

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

Sacramento, California, 95825, United States

RECRUITING

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Medeye Associates - Research

Miami, Florida, 33143, United States

RECRUITING

Advanced Research, LLC

Pensacola, Florida, 32503, United States

RECRUITING

Retina Associates

Elmhurst, Illinois, 60126, United States

RECRUITING

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

RECRUITING

Mississippi Retina Assoc

Madison, Mississippi, 39110, United States

RECRUITING

Charleston Neuroscience Institute

Charleston, South Carolina, 29414-5896, United States

RECRUITING

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

Ladson, South Carolina, 29456, United States

RECRUITING

Palmetto Retina Center, Florence (RCA)

West Columbia, South Carolina, 29169, United States

RECRUITING

Texas Retina Associates (TRA) - Arlington

Arlington, Texas, 76012, United States

RECRUITING

Texas Retina Associates (TRA) - Dallas Main

Dallas, Texas, 75231, United States

RECRUITING

Texas Retina Associates - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Retina Consultants of Texas - Schertz

Schertz, Texas, 78154, United States

RECRUITING

Vitreoretinal Associates of Washington

Bellevue, Washington, 98004-3779, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

aflibercept

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 12, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (18)