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

August 21, 2026 updated by: Amgen

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835-3432
        • Recruiting
        • Retina Consultants of Orange County
      • Long Beach, California, United States, 90607
        • Recruiting
        • South Coast Retina Center - RCA
      • Modesto, California, United States, 95356
        • Recruiting
        • Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
      • Pasadena, California, United States, 91107
        • Recruiting
        • California Eye Specialists Medical Group, Inc
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
      • Santa Barbara, California, United States, 93103
        • Recruiting
        • California Retina Consultants
    • Colorado
      • Colorado Springs, Colorado, United States, 80909-1183
        • Recruiting
        • Retina Consultants of Southern Colorado (Colorado Springs)- RCA
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • Retina Consultants of Southern Colorado (Pueblo)- RCA
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Retina Associates (RCA)
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Retina Group of New England
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Medeye Associates - Research
      • Naples, Florida, United States, 34103-4457
        • Recruiting
        • Retina Consultants of Southwest Florida - Naples
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Advanced Research, LLC
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Retina Associates
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Associated Vitreoretinal and Uveitis Consultants
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • The Retina Care Center- Baltimore (PRISM Vision Group)
      • Hagerstown, Maryland, United States, 21740-5846
        • Recruiting
        • Mid Atlantic Retina Specialists
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Retina Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Retina Consultants of Minnesota
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Recruiting
        • Mississippi Retina Assoc
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • The Retina Institute, Research Retina Institute (RCA)
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Envision Ocular, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Vision Research Center Eye Associates of New Mexico
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina Vitreous Surgeons of CNY, PC
      • Oceanside, New York, United States, 11572
        • Recruiting
        • Ophthalmic Consultants of Long Island - Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27607-7514
        • Recruiting
        • North Carolina Retina Associates
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • NC Retina Associates-RCA
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Midwest Retina - Main Office
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704-4801
        • Recruiting
        • Eye Care Specialists - Kingston
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Recruiting
        • Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)
      • Charleston, South Carolina, United States, 29414-5896
        • Recruiting
        • Charleston Neuroscience Institute
      • Columbia, South Carolina, United States, 29169
        • Recruiting
        • Palmetto Retina Center - Main (RCA)
      • Ladson, South Carolina, United States, 29456
        • Recruiting
        • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
      • Mt. Pleasant, South Carolina, United States, 29464
        • Recruiting
        • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Palmetto Retina Center, Florence (RCA)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina PC
    • Texas
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Texas Retina Associates (TRA) - Arlington
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates - Ophthalmology/Retina
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas - Bellaire
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associates (TRA) - Dallas Main
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Retina Associates - Fort Worth
      • Houston, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas - Katy Retina Center
      • Katy, Texas, United States, 77494
        • Recruiting
        • Retina Consultants of Texas - The Woodlands
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retinal Consultants of Texas- San Antonio
      • Schertz, Texas, United States, 78154
        • Recruiting
        • Retina Consultants of Texas - Schertz
      • Willow Park, Texas, United States, 76087
        • Recruiting
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Retina Associates of Utah - Retina Specialist
    • Virginia
      • Falls Church, Virginia, United States, 22042-2349
        • Recruiting
        • Emerson Clinical Research- Virginia Retina Specialists
    • Washington
      • Bellevue, Washington, United States, 98004-3779
        • Recruiting
        • Vitreoretinal Associates of Washington
      • Silverdale, Washington, United States, 98383
        • Recruiting
        • Retina Center NW PLLC
      • Spokane, Washington, United States, 99204-2509
        • Recruiting
        • Spokane Eye Clinic (OCT and optical exam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: ABP 938 8 mg
IVT injection
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.
Drug: Aflibercept (US) 8 mg
IVT injection
Other Names:
  • EYLEA HD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Time Frame: Week 16
Week 16
Change from Baseline in BCVA as measured by ETDRS letter score
Time Frame: Baseline to Week 48
Baseline to Week 48
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT
Time Frame: Baseline to Week 48
Baseline to Week 48
Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
Time Frame: Week 16 and Week 20
Week 16 and Week 20
Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
Time Frame: Week 48
Week 48
Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Non-Ocular TEAEs
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Free serum concentrations of ABP 938 8 mg
Time Frame: Week 16, week 24 and 48 (End of Study)
Week 16, week 24 and 48 (End of Study)
Free serum concentrations of Aflibercept (US) 8 mg
Time Frame: Week 16, week 24, and 48 (End of Study)
Week 16, week 24, and 48 (End of Study)
Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy
Time Frame: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy
Time Frame: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250115
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523500-72-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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