This study will evaluate the efficacy, safety, durability, and pharmacokinetics of VIS-101 administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
Change in BCVA from baseline to average of Weeks 20, 24, and 28
BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity
Time frame: From Baseline through Week 28
Change in BCVA from baseline
Time frame: Throughout week 48
Dosing interval
Time frame: Throughout week 48
Number of injections
Time frame: Throughout week 44
Change in CST from baseline
Time frame: Throughout week 28 and week 48
Proportion of participants with no intraretinal fluid
Time frame: Throughout week48
Proportion of participants with no subretinal fluid
Time frame: Throughout week48
Proportion of participants with no intraretinal and subretinal fluid
Time frame: Throughout week48
Proportion of participants with no intraretinal cysts
Time frame: Throughout week48
Proportion of participants with no retinal pigment epithelial (RPE) detachment
Time frame: Throughout week48
Change in total area of CNV lesion from baseline
Clinical Trial Information Center, Everest Medicines
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Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
Time frame: Throughout week 28 and 48
Change in total leakage area from baseline
Time frame: Throughout week 28 and 48
Incidence and severity of post-treatment adverse events, treatment-related adverse events and serious adverse events
Time frame: Throughout week48