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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 (A study to compare a new study medicine, ABP 938 8 mg with EYLEA HD (aflibercept 8 mg) in participants with Neovascular Age-related Macular Degeneration.)

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 Call Center

Amgen

One Amgen Center Drive, Thousand Oaks, CA 91320 1799, US

medinfo@amgen.com

Rosario Chikako

Parexel International Inc.

Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo, 104-0033

+81-80-8929-3137

Clinicaltrial-registration@parexel.com

Pending

Aug. 24, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1. Men or women >= 50 years old, capable of giving signed informed consent
2. Active, treatment-naive 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)
3. Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
4. The BCVA letter score >= 24 and <= 78 letters, in the SE
5. 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

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

Neovascular Age-related Macular Degeneration

Experimental: ABP 938 8 mg
- Drug: ABP 938 8 mg
(IVT injection)

Active Comparator: Aflibercept (US) 8 mg
- Drug: Aflibercept (US) 8 mg
(IVT injection)
(Other Names: EYLEA HD)

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

- 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]
- Change from Baseline in BCVA as measured by ETDRS letter score [Time Frame: 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]
- Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48 [Time Frame: 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]
- Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT [Time Frame: 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]
- Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments [Time Frame: Week 48]
- Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline up to Week 48]
- Number of Participants Who Experienced Non-Ocular TEAEs [Time Frame: Baseline up to Week 48]
- Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) [Time Frame: Baseline up to Week 48]
- Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: Baseline up to Week 48]
- Number of Participants Who Developed Binding Antidrug Antibodies (ADAs) [Time Frame: Baseline up to Week 48]
- Free serum concentrations of ABP 938 8 mg [Time Frame: 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)]
- 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)]
- 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)]

+81-3-3411-0111

June. 30, 2026

Yes

Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. 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. URL: https://www.amgen.com/datasharing

United States