South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study)
NCT07753616 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-08-07
Summary
The YOSEMITE and RHINE trials, which studied DMO treated with faricimab, had a majority Caucasian cohort, and the small Asian cohort was East Asian, with no South Asian representation. South Asians have a much higher prevalence of diabetes and its ophthalmic complication of DMO.
The SEAFAR study is designed to address this unmet need by specifically evaluating faricimab in a UK-based South Asian cohort with diabetic macular oedema (DMO), delivered via a pragmatic treat-and-extend regimen, for clinically meaningful visual acuity gains, durable anatomic control of DMO, and an acceptable safety profile at week 88 in South Asian patients, with interim benefits by week 52.
Conditions
Interventions
- DRUG
-
Intravitreal anti-VEGF injection, Faricimab
Intravitreal anti-VEGF injection, Faricimab
Sponsors & Collaborators
-
Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust
lead OTHER_GOV
Principal Investigators
-
Bushra Mushtaq, FRCS · Birmingham and Midland Eye Centre SWBH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-11-01
- Primary Completion
- 2029-11-01
- Completion
- 2029-11-01
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