NCT03823287

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Wet Macular Degeneration

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
DRUG	Aflibercept	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).
PROCEDURE	Sham Procedure	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.

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-10-26
• Completion: 2022-01-18
• First posted: 2019-01-30
• Last updated: 2025-07-23
• Results posted: 2022-05-04

Locations

161 sites across 15 countries: United States, Canada, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study