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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523500-72-00 | EU Trial (CTIS) Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP 938 8 mg | Drug | IVT injection |
| |
| Aflibercept (US) 8 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score | Baseline and Week 12 |
| Measure | Description | 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) | Week 16 | |
| Change from Baseline in BCVA as measured by ETDRS letter score |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast Retina Center - RCA | Recruiting | Long Beach | California | 90607 | United States | |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| Drug |
IVT injection |
|
|
| 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 |
| Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT | Baseline to Week 48 |
| Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments | Week 16 and Week 20 |
| Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments | Week 48 |
| Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 48 |
| Number of Participants Who Experienced Non-Ocular TEAEs | Baseline up to Week 48 |
| Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) | Baseline up to Week 48 |
| Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Week 48 |
| Number of Participants Who Developed Binding Antidrug Antibodies (ADAs) | Baseline up to Week 48 |
| Free serum concentrations of ABP 938 8 mg | Week 16, week 24 and 48 (End of Study) |
| Free serum concentrations of Aflibercept (US) 8 mg | 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 | 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 | From Baseline (day 1, week 0) to Day 29 (pre dose week 4) |
| California Eye Specialists Medical Group, Inc |
| Recruiting |
| Pasadena |
| California |
| 91107 |
| United States |
| Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA) | Recruiting | Sacramento | California | 95825 | United States |
| California Retina Consultants | Recruiting | Santa Barbara | California | 93103 | United States |
| Medeye Associates - Research | Recruiting | Miami | Florida | 33143 | United States |
| Retina Consultants of Southwest Florida - Naples | Recruiting | Naples | Florida | 34103-4457 | United States |
| Advanced Research, LLC | Recruiting | Pensacola | Florida | 32503 | United States |
| Retina Associates | Recruiting | Elmhurst | Illinois | 60126 | United States |
| Associated Vitreoretinal and Uveitis Consultants | Recruiting | Carmel | Indiana | 46032 | United States |
| Mid Atlantic Retina Specialists | Recruiting | Hagerstown | Maryland | 21740-5846 | United States |
| Retina Specialists | Recruiting | Towson | Maryland | 21204 | United States |
| Retina Consultants of Minnesota | Recruiting | Edina | Minnesota | 55435 | United States |
| Mississippi Retina Assoc | Recruiting | Madison | Mississippi | 39110 | United States |
| The Retina Institute, Research Retina Institute (RCA) | Recruiting | St Louis | Missouri | 63128 | United States |
| Vision Research Center Eye Associates of New Mexico | Recruiting | Albuquerque | New Mexico | 87109 | United States |
| Ophthalmic Consultants of Long Island - Research | Recruiting | Oceanside | New York | 11572 | United States |
| Charleston Neuroscience Institute | Recruiting | Charleston | South Carolina | 29414-5896 | United States |
| Palmetto Retina Center - Main (RCA) | Recruiting | Columbia | South Carolina | 29169 | United States |
| Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA) | Recruiting | Ladson | South Carolina | 29456 | United States |
| Palmetto Retina Center, Florence (RCA) | Recruiting | West Columbia | South Carolina | 29169 | United States |
| Texas Retina Associates (TRA) - Arlington | Recruiting | Arlington | Texas | 76012 | United States |
| Austin Retina Associates - Ophthalmology/Retina | Recruiting | Austin | Texas | 78705 | United States |
| Texas Retina Associates (TRA) - Dallas Main | Recruiting | Dallas | Texas | 75231 | United States |
| Texas Retina Associates - Fort Worth | Recruiting | Fort Worth | Texas | 76104 | United States |
| Retina Consultants of Texas - Katy Retina Center | Recruiting | Houston | Texas | 77401 | United States |
| Retina Consultants of Texas - Schertz | Recruiting | Schertz | Texas | 78154 | United States |
| Retina Associates of Utah - Retina Specialist | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Vitreoretinal Associates of Washington | Recruiting | Bellevue | Washington | 98004-3779 | United States |
| Retina Center NW PLLC | Recruiting | Silverdale | Washington | 98383 | United States |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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