NCT05224102

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

A Phase IV, Multicenter, Open-Label, Single-Arm Study to Investigate Faricimab (RO6867461) Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Faricimab	Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.

Timeline

• Start date: 2022-02-28
• Primary completion: 2027-01-26
• Completion: 2027-01-26
• First posted: 2022-02-04
• Last updated: 2026-03-02

Locations

43 sites across 4 countries: United States, India, Kenya, Puerto Rico

Regulatory

• FDA-regulated drug study