At a glance
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A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)
In Brief
A Phase 3 clinical trial evaluating Faricimab, Aflibercept, and 1 other intervention for Wet Macular Degeneration. Completed, enrolled 671 participants across 161 sites in 15 countries.
Detailed Summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab 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 Details
Timeline
Interventions
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
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).
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.