Recruiting
Sponsor ID
20250115

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

Sponsor ID
20250115
Clinicaltrials.gov ID
NCT07614776
EUCTIS ID
2025-523500-72-00
EudraCT ID
N/A

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)

Additional Study Details

Phase
Phase 3
Product
ABP 938
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
304
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

Timeframe: Baseline and Week 12

Secondary Outcome Measures

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)

Locations

Location
Status
Contact Us
Location
Advanced Research, LLC
Pensacola, Florida, United States, 32503
Status
Recruiting
Location
Texas Retina Associates (TRA) - Arlington
Arlington, Texas, United States, 76012
Status
Recruiting
Location
Retina Consultants of Minnesota
Edina, Minnesota, United States, 55435
Status
Recruiting
Location
Texas Retina Associates (TRA) - Dallas Main
Dallas, Texas, United States, 75231
Status
Recruiting
Location
Texas Retina Associates - Fort Worth
Fort Worth, Texas, United States, 76104
Status
Recruiting
Location
South Coast Retina Center - RCA
Long Beach, California, United States, 90607
Status
Recruiting
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