South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study)

NCT07753616 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: SWB/SPON/26/04Agreed
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Diabetic Macular Edema

Keywords

diabetic macular oedema; treat and extend; faricimab; south asian; indian; pakistani; bangladeshi; sri lankan

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 88 (+/- 14 days)

Secondary Outcomes (13)

• Distribution of Maximum Dosing Interval Achieved

  Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)

• Change From Baseline in Central Subfield Thickness (CST)

  Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)

• Proportion of Participants With Absence of Diabetic Macular Oedema

  Week 52 (+/- 14 days) and Week 88 (+/- 14 days)

• Proportion of Participants With Absence of Intraretinal Fluid

  Week 52 (+/- 14 days) and Week 88 (+/- 14 days)

• Proportion of Participants Gaining >=5, >=10 and >=15 ETDRS Letters From Baseline

  Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)

Study Arms (1)

single arm DMO treated with Faricimab

OTHER

Drug: Intravitreal anti-VEGF injection, Faricimab

Interventions

Intravitreal anti-VEGF injection, Faricimab DRUG

Intravitreal anti-VEGF injection, Faricimab

single arm DMO treated with Faricimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Ability and willingness to provide written informed consent and comply with all study procedures and follow-up.

You may not qualify if:

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• 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.
• Any ocular condition that could confound macular assessment or contribute to irreversible vision loss in the study eye, including:
• Retinal vein occlusion
• Significant epiretinal membrane
• Tractional retinal detachment involving the posterior pole
• Macular atrophy
• Foveal scarring

Sponsors & Collaborators

• Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust: lead

Related Publications (9)

• Okada AA, Palestine AG, Kramer M, Jabs DA, Standardization Of Uveitis Nomenclature Sun Working Group. Reply to Comment on: Classification Criteria for Behcet Disease Uveitis. Am J Ophthalmol. 2022 Mar;235:339-340. doi: 10.1016/j.ajo.2021.10.020. Epub 2021 Oct 27. No abstract available.

  PMID: 34715075 BACKGROUND

• Ishida S, Chen SJ, Murata T, Ogura Y, Ruamviboonsuk P, Sakamoto T, Fujita T, Kawano M, Ohsawa S, Abreu F, Haskova Z, Ives J, Silverman D, Yoon YH; YOSEMITE and RHINE Investigators. Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. Asia Pac J Ophthalmol (Phila). 2023 Sep-Oct 01;12(5):451-459. doi: 10.1097/APO.0000000000000634. Epub 2023 Sep 22.

  PMID: 37851562 BACKGROUND

• Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.

  PMID: 35085503 BACKGROUND

• Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.

  PMID: 27651226 BACKGROUND

• Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, Gibson A, Sy J, Rundle AC, Hopkins JJ, Rubio RG, Ehrlich JS; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801. doi: 10.1016/j.ophtha.2011.12.039. Epub 2012 Feb 11.

  PMID: 22330964 BACKGROUND

• Raymond NT, Varadhan L, Reynold DR, Bush K, Sankaranarayanan S, Bellary S, Barnett AH, Kumar S, O'Hare JP; UK Asian Diabetes Study Retinopathy Study Group. Higher prevalence of retinopathy in diabetic patients of South Asian ethnicity compared with white Europeans in the community: a cross-sectional study. Diabetes Care. 2009 Mar;32(3):410-5. doi: 10.2337/dc08-1422. Epub 2008 Dec 15.

  PMID: 19074992 BACKGROUND

• Tillin T, Hughes AD, Godsland IF, Whincup P, Forouhi NG, Welsh P, Sattar N, McKeigue PM, Chaturvedi N. Insulin resistance and truncal obesity as important determinants of the greater incidence of diabetes in Indian Asians and African Caribbeans compared with Europeans: the Southall And Brent REvisited (SABRE) cohort. Diabetes Care. 2013 Feb;36(2):383-93. doi: 10.2337/dc12-0544. Epub 2012 Sep 10.

  PMID: 22966089 BACKGROUND

• Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.

  PMID: 26605370 BACKGROUND

• Tan GS, Cheung N, Simo R, Cheung GC, Wong TY. Diabetic macular oedema. Lancet Diabetes Endocrinol. 2017 Feb;5(2):143-155. doi: 10.1016/S2213-8587(16)30052-3. Epub 2016 Aug 3.

  PMID: 27496796 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

faricimab

Study Officials

• Bushra Mushtaq, FRCS

  Birmingham and Midland Eye Centre SWBH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Trinham, RM & G Manager SWBH Trust

CONTACT

+44 7790944789; charlotte.trinham1@nhs.net

Yu Jeat Chong, FRCophth

CONTACT

+447515497877; yujeat.chong@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-08