A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
≥50 years of age at time of consent
Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
History of retinal detachment in the study eye
History of or presence of active inflammation in either eye
Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
Parallel
4D-150 IVT (3E10 vg/eye)
Biological/VaccineIf 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) Injection 2 mg (0.05mL)
Biological/VaccineEylea (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
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104
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