CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 940 enrolled
Drug / intervention
Aflibercept +2 moredrug
Likely dose
Aflibercept 2 mgfrom 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/NCT03622580
NCT03622580Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

Hoffmann-La Roche·interventional·Posted Aug 9, 2018·Updated Jul 11, 2025

In Brief

A Phase 3 clinical trial evaluating Aflibercept, Faricimab, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 940 participants across 185 sites in 16 countries.

Detailed Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesAustria, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 9, 2018
Enrollment StartSep 5, 2018
Primary CompletionOct 20, 2020
Study CompletionSep 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.9 years ago

Interventions

Afliberceptdrug

Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Faricimabdrug

Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.

Sham Procedureprocedure

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.