CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 671 enrolled
Drug / intervention
Faricimab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03823287
NCT03823287Phase 3Completed

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)

Hoffmann-La Roche·interventional·Posted Jan 30, 2019·Updated Jul 23, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartFeb 19, 2019
Primary CompletionOct 26, 2020
Study CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.4 years ago

Interventions

Faricimabdrug

Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

Afliberceptdrug

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).

Sham Procedureprocedure

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.