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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
304
IVT injection
IVT injection
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
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Retina Consultants of Orange County
Fullerton, California, United States
RECRUITINGSouth Coast Retina Center - RCA
Long Beach, California, United States
RECRUITINGRetinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
Modesto, California, United States
RECRUITINGCalifornia Eye Specialists Medical Group, Inc
Pasadena, California, United States
RECRUITINGRetinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
Sacramento, California, United States
RECRUITINGCalifornia Retina Consultants
Santa Barbara, California, United States
RECRUITINGRetina Consultants of Southern Colorado (Colorado Springs)- RCA
Colorado Springs, Colorado, United States
RECRUITINGRetina Consultants of Southern Colorado (Pueblo)- RCA
Colorado Springs, Colorado, United States
RECRUITINGColorado Retina Associates (RCA)
Lakewood, Colorado, United States
RECRUITINGRetina Group of New England
Waterford, Connecticut, United States
RECRUITING...and 54 more locations
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)