A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
Eylea (aflibercept) will be administered at applicable visits
Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52
Time frame: 52 Weeks
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
Time frame: 104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
Time frame: 104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
Time frame: 104 Weeks
Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104
Time frame: 104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
Time frame: 104 Weeks
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