NCT03622580

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 940 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept	Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
DRUG	Faricimab	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.
PROCEDURE	Sham Procedure	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.

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-10-20
• Completion: 2021-09-03
• First posted: 2018-08-09
• Last updated: 2025-07-11
• Results posted: 2022-03-22

Locations

185 sites across 16 countries: United States, Austria, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study