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About
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).
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Inclusion criteria
Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
Diagnosis of active myopic CNV in the study eye:
BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
Ability to comply with the study protocol, in the Investigator's judgment
Other protocol-defined inclusion criteria apply
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
280 participants in 2 patient groups
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Central trial contact
Reference Study ID Number: CR44829 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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