NCT04432831

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,479 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
OTHER	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. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Timeline

• Start date: 2020-08-05
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2020-06-16
• Last updated: 2026-02-09
• Results posted: 2024-10-30

Locations

320 sites across 30 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study