The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.
Approximately 566 subjects will be randomized in approximately 126 global sites. This study consists of a screening period of up to 4 weeks, after which subjects will receive investigational product for 48 weeks, followed by a safety follow-up period to week 52, for a total study duration of up to 56 weeks. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by IVT injection. At week 8, subjects will be assessed for the primary endpoint. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to week 8, in order to assess the efficacy of ABP 938 compared to aflibercept. Subjects will then be re-randomized at week 16 in a masked fashion such that: * Subjects initially randomized to ABP 938 (Treatment Group A) will continue to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48 * Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized in a 1:1 ratio to either continue on aflibercept (Treatment Group B1) or transition to ABP 938 (Treatment Group B2) by IVT injection every 8 weeks from week 16 until week 48
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
576
Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
Mean Change From Baseline in BCVA at Week 8
BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.
Time frame: Baseline and Week 8
Percentage of Participants Who Maintained Vision at Week 52
A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline.
Time frame: Week 52
Mean Change From Baseline in BCVA
BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.
Time frame: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8
Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.
Time frame: Week 8
Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52
Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.
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Associated Retina Consultants, Ltd. - Research
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Sacramento, California, United States
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Time frame: Week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size
CNV area size was measured by fluorescein angiography. Change from Baseline calculated as observed post-baseline value - Baseline value.
Time frame: Baseline and Weeks 8, 16, 24, and 52
Mean Change From Baseline in Central Subfield Thickness (CST)
CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography. Change from Baseline calculated as observed post-baseline value - Baseline value.
Time frame: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: * Results in death * Life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event.
Time frame: Up to Week 52
Number of Participants Developing Binding Antidrug Antibodies (ADAs)
Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported.
Time frame: Baseline up to Week 52