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
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)
Protocol Summary
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Timeframe: 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)
Timeframe: Week 16
Change from Baseline in BCVA as measured by ETDRS letter score
Timeframe: Baseline to Week 48
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
Timeframe: Baseline to Week 24
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48
Timeframe: Baseline to Week 48
Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)
Timeframe: Baseline to Week 48
Change From Baseline in Central Subfield Thickness (CST) as Measured by SD‑OCT
Timeframe: Baseline to Week 48
Percentage of Participants Who Met Protocol‑Defined DRA Criteria, as Determined by Protocol‑Specified Clinical and Imaging Assessments
Timeframe: Week 16 and Week 20
Percentage of Participants Who Met Protocol‑Defined DRA Criteria, as Determined by Protocol‑Specified Clinical and Imaging Assessments
Timeframe: Week 48
Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Baseline up to Week 48
Number of Participants Who Experienced Non-Ocular TEAEs
Timeframe: Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)
Timeframe: Baseline up to Week 48
Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: Baseline up to Week 48
Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)
Timeframe: Baseline up to Week 48
Free serum concentrations of ABP 938 8 mg
Timeframe: Week 16, week 24 and 48 (End of Study)
Free serum concentrations of Aflibercept (US) 8 mg
Timeframe: 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
Timeframe: 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
Timeframe: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)