A Phase 3 interventional study of ABP 938 8 mg and Aflibercept (US) 8 mg in Neovascular Age-related Macular Degeneration and nAMD, sponsored by Amgen. Recruiting at 81 sites in 9 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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)
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 304 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
IVT injection
Also known as: 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)
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.amgen.com
Started May 2026 (actual). Primary completion is estimated for Jul 2027, 14 months after the start.
Of 77 industry-sponsored phase 3 interventional studies under Macular Degeneration, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 14 months is below that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 20 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Aflibercept