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.
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.
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.
Single group
Intravitreal anti-VEGF injection, Faricimab
DrugIntravitreal anti-VEGF injection, Faricimab
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from baseline in best corrected visual acuity in the study eye, measured as ETDRS letter score.
Distribution of Maximum Dosing Interval Achieved
Proportion of participants at each maximum dosing interval achieved (Q8W, Q12W, Q16W, Q20W, Q24W).
Change From Baseline in Central Subfield Thickness (CST)
Change from baseline in central subfield thickness measured by spectral domain optical coherence tomography.
Proportion of Participants With Absence of Diabetic Macular Oedema
Proportion of participants with central subfield thickness below the device-specific inclusion threshold.
Proportion of Participants With Absence of Intraretinal Fluid
Proportion of participants with absence of intraretinal fluid (IRF) on spectral domain optical coherence tomography (Heidelberg SD-OCT), based on qualitative fluid status assessment.
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