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

Conditions

• Neovascular Age-related Macular Degeneration
• nAMD

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ABP 938 8 mg — DRUG
  IVT injection
• Aflibercept (US) 8 mg — DRUG
  IVT injection

Study Details

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)

Key Dates

First listed

May 29, 2026

Start date

May 27, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2027

Completion

Jan 12, 2028

Study Design

Enrollment

304 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

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

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (36)

Find similar trials in Fullerton, CA

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