Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema
Lead Sponsor:
Genentech, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 consis...
Eligibility Criteria
Inclusion
- Main Phase General
- Self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; or self-identify as Asian Indian residents of the Indian subcontinent
- Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) and/or oral anti-hyperglycemic agents for the treatment of diabetes
- Hemoglobin A1c (HbA1c) ≤10% (Note: up to 20% of participants enrolled may have HbA1c up to 12%)
- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol
- Main Phase Ocular Inclusion Criteria for Study Eye:
- Intravitreal (IVT) treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye)
- Diabetic macular edema, defined as macular thickening by SD-OCT involving the center of the macula
- BCVA letter score of 73 to 20 letters (both inclusive) using the ETDRS protocol at the initial testing distance of 4 meters at the baseline visit (Day 1)
- Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
- Long-Term Extension (LTE)
- Enrollment in and completion of the main study, without discontinuation from study or study drug treatment
- Signed LTE-phase Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol
Exclusion
- Main Phase General
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2027
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT05224102
Start Date
February 28 2022
End Date
January 26 2027
Last Update
December 2 2025
Active Locations (43)
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1
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
2
Win Retina
Arcadia, California, United States, 91006
3
Retinal Diagnostic Center
Campbell, California, United States, 95008
4
Retina Consultants of Orange County
Fullerton, California, United States, 92835