South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, … (NCT07753616) | Clinical Trial Compass
Not Yet RecruitingPhase 4
South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study)
120 participantsStarted 2026-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who self-identify themselves as of South Asian origin. Including Indian, Pakistani, Bangladeshi and Sri Lankan.
. Adults aged ≥18 years at time of consent.
. Documented diagnosis of type 1 or type 2 diabetes mellitus.
. Best-corrected visual acuity (BCVA) of 20-73 ETDRS letters, corresponding approximately to 6/12 to 6/120 Snellen (metres) in the study eye.
. Centre-involving diabetic macular oedema (DMO) confirmed on SD-OCT, with a central subfield thickness (CST) ≥400 µm, in line with UK NICE guidance in the treatment naïve patients (75% of the cohort). 25% of cohort is previously treated DMO where treatment commenced within 3 years of the screening visit and responded to the anti VEGF, reviewed during this period and developed any clinically significant recurrence of DMO, with vision at least 6/18 or better in the enrolled eye.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Timeframe: Baseline and Week 88 (+/- 14 days)
Trial details
NCT IDNCT07753616
SponsorBirmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust
. Decreased visual acuity attributable primarily to DMO.
. Both eyes may be eligible; however, the eye with the higher CST will be designated as the study eye.
. Male or female participants are eligible. Women of childbearing potential must agree to remain abstinent or use highly effective contraception during the study and for at least 3 months after the final dose.
Exclusion criteria
. Untreated diabetes mellitus, or initiation of oral or injectable anti-diabetic therapy within 3 months prior to Day 1.
. Uncontrolled blood pressure: systolic \>180 mmHg or diastolic \>100 mmHg at rest.
. Pregnant or breastfeeding women, or intention to become pregnant during the study period.
. Pan retinal photocoagulation (PRP) or macular laser in the study eye within 3 months prior to Day 0.
. Intraocular or periocular corticosteroid therapy in the study eye within 6 months prior to Day 0.
. Previous treatment with Fluocinolone acetonide (Iluvien) in the study eye.
. Active proliferative diabetic retinopathy in the study eye.
. Active ocular or periocular infection, or active intraocular inflammation, in the study eye.