About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women ≥ 50 years old, capable of giving signed informed consent
Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
Disqualifiers
Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
Scar, fibrosis, or atrophy involving the central subfield in the study eye
Scar or fibrosis involving > 50% of the total lesion in the study eye
Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
Trial design
Parallel
Treatments tested in this trial
ABP 938 8 mg
DrugIVT injection
Aflibercept (US) 8 mg
DrugIVT injection
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Secondary outcomes
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)
Change from Baseline in BCVA as measured by ETDRS letter score
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48