A Phase 4 interventional study of Intravitreal anti-VEGF injection, Faricimab in Diabetic Macular Edema, sponsored by Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust · Phase 4, Interventional, and Treatment
Among 50 studies testing bevacizumab in Macular Edema — 3 open to participants now, 3 under way, 2 of them phase 3. Bevacizumab · Macular Edema.
Among the 50 studies testing bevacizumab in Macular Edema, this one is the 15th largest by planned enrollment of the 46 interventional ones, is one of 2 that started in 2026, is one of 13 in phase 4, and was the 49th registered.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 120 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →3 of the 50 studies testing bevacizumab in Macular Edema are open now, in 2 countries. Each count lists the studies.
Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →
Of the 44 Macular Edema studies recruiting now, 31 (70%) set no upper age limit and 7 (16%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
Median enrollment 63 across the 46 interventional studies. Of the 33 that completed or were terminated, 13 (39%) have results posted.
2 of 50 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust as lead sponsor.
Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust has 1 study filed under Macular Edema — fewer than ten, so there is no comparison to draw.
1 of the studies testing bevacizumab in Macular Edema that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07897630Phase 3Khyber Teaching HospitalSuprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Diabetic Macular Edema | 2027-10 |
Among the 50 studies testing bevacizumab in Macular Edema, from their registry updates:
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.
Diabetic macular oedema (DMO), characterised by accumulation of extracellular fluid in the macula due to breakdown of the blood-retinal barrier, is the most common cause of sight-threatening diabetic retinopathy. It affects approximately one in fifteen people with diabetes, corresponding to more than 20 million individuals worldwide, and is a leading cause of vision impairment. The risk of diabetes is not equally distributed across populations. In the UK, individuals of South Asian heritage (Indian, Pakistani, Bangladeshi, Sri Lankan) have a 2-4 times higher risk of developing type 2 diabetes compared to those of European ancestry, with onset often at a younger age and at lower body mass index (BMI) thresholds. They are also shown to have a higher prevalence of retinopathy and maculopathy compared with White Europeans, with worse systemic risk factors (such as HbA1c, blood pressure, cholesterol). Despite this, there is limited trial-based evidence addressing treatment outcomes for these high-risk groups.
Anti-vascular endothelial growth factor (anti-VEGF) therapy has transformed the management of DMO. Pivotal trials such as RISE/RIDE and VIVID/VISTA established the efficacy of ranibizumab and aflibercept in improving visual outcomes and reducing retinal thickness. More recently, faricimab, a bispecific antibody targeting VEGF-A and Angiopoietin-2, has demonstrated efficacy with the potential for extended durability. In the YOSEMITE and RHINE trials, faricimab provided comparable or superior visual and anatomical outcomes to aflibercept 2mg, with a substantial proportion of patients achieving treatment intervals of up to every 16 weeks.
While YOSEMITE and RHINE enrolled over 1,800 patients, the majority of them were non-Asian (n=1747 versus n=144 for Asians). Subgroup analyses for participants in YOSEMITE and RHINE from Asian countries demonstrated broadly similar outcomes between Asian and non-Asian groups. However, the Asian participants were predominantly from East Asia (China, Japan, Korea, Singapore, Taiwan), which means that these findings cannot be extrapolated to South Asian patients given their potentially distinct genetic, biological, and lifestyle risk profiles. Notably, the ELEVATUM trial, designed to evaluate faricimab in underrepresented groups (African-Caribbean, Hispanic, Pacific Islander), similarly did not include adequate representation of South Asians. Thus, a critical evidence gap remains.
The SEAFAR study is designed to address this unmet need by specifically evaluating faricimab in a UK-based South Asian cohort with DMO. The rationale is threefold:
A pragmatic, Phase IV, single-arm, open-label design is chosen to mirror routine clinical practice while still enabling comparison with previous trial data. By adopting a treat-and-extend protocol up to 24-week intervals, this study will generate real-world, ethnically relevant evidence on the efficacy, durability and safety of faricimab in South Asian patients with DMO.
HYPOTHESIS AND OBJECTIVES
Faricimab, delivered via a pragmatic treat-and-extend regimen, will produce 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. All participants will have a forced study visit at Week 52 and Week 88 (exit visit) even if not aligned with their treatment interval.
Primary objective:
1) To evaluate the change from baseline in best corrected visual acuity at week 88 (+/- 14 days) in the study eye, with best responsive patients completing a 24-week extension of their active dosing phase and initiating their observation phase.
Secondary objectives:
Diabetic retinopathy severity score (DRSS):
EXPECTED RISKS AND BENEFITS
Risks:
Participants will experience no study-specific risks. Clinical risks as per standard of care include:
Benefits:
Wider benefits to society and healthcare include the generation of population-specific evidence for the efficacy, durability, and safety of faricimab in South Asian patients with DMO, who have historically been underrepresented in pivotal clinical trials. This may support equitable access to evidence-based care and inform NHS service planning by demonstrating whether extended dosing intervals can reduce treatment burden and service demand.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects must meet all of the following inclusion criteria to participate:
Exclusion Criteria:
All subjects meeting any of the following exclusion criteria at baseline will be excluded from participation:
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Any ocular condition that could confound macular assessment or contribute to irreversible vision loss in the study eye, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intravitreal anti-VEGF injection, Faricimab
Drug pages: Bevacizumab · Faricimab
Intravitreal 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.
Time frame: Baseline and Week 88 (+/- 14 days)
Distribution of Maximum Dosing Interval Achieved
Proportion of participants at each maximum dosing interval achieved (Q8W, Q12W, Q16W, Q20W, Q24W).
Time frame: Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)
Change From Baseline in Central Subfield Thickness (CST)
Change from baseline in central subfield thickness measured by spectral domain optical coherence tomography.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Proportion of Participants With Absence of Diabetic Macular Oedema
Proportion of participants with central subfield thickness below the device-specific inclusion threshold.
Time frame: Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
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.
Time frame: Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Proportion of Participants Gaining >=5, >=10 and >=15 ETDRS Letters From Baseline
Proportion of participants gaining 5 or more, 10 or more, and 15 or more letters from baseline in best corrected visual acuity, assessed using ETDRS charts.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Proportion of Participants Losing >=5, >=10 and >=15 ETDRS Letters From Baseline
Proportion of participants losing 5 or more, 10 or more, and 15 or more letters from baseline in best corrected visual acuity, assessed using ETDRS charts.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Change From Baseline in Vision-Related Quality of Life (NEI VFQ-25)
Change from baseline in vision-related quality of life, assessed using the VFQ-25 questionnaire, collected on paper or electronically depending on site capability.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Change From Baseline in Health-Related Quality of Life (EQ-5D)
Change from baseline in health-related quality of life, assessed using the EQ-5D questionnaire, collected on paper or electronically depending on site capability.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Proportion of Participants With a 2-Step or 3-Step Improvement in Diabetic Retinopathy Severity Score (DRSS) From Baseline
Proportion of participants with a 2-step or 3-step improvement from baseline in Diabetic Retinopathy Severity Score, documented in both eyes from wide-field fundus photographs.
Time frame: Baseline, Week 52 (+/- 14 days) and Week 88 (+/- 14 days)
Number of Participants With Ocular Adverse Events
Number of participants with ocular adverse events. Adverse events will be coded and summarised by frequency, severity, and relationship to treatment. Ocular safety outcomes, including intraocular pressure and events such as endophthalmitis, retinal vasculitis, and retinal vascular occlusion, will be tabulated separately.
Time frame: Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)
Number of Participants With Systemic Adverse Events
Number of participants with systemic adverse events. Adverse events will be coded and summarised by frequency, severity, and relationship to treatment.
Time frame: Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with serious adverse events, defined per protocol as any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Events will be coded and summarised by frequency, severity, and relationship to treatment.
Time frame: Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)
Number of Participants With Suspected Unexpected Serious Adverse Reactions (SUSARs)
Number of participants with Suspected Unexpected Serious Adverse Reactions, defined as adverse reactions that are both unexpected and serious.
Time frame: Baseline through Week 88 (+/- 14 days), with interim assessment at Week 52 (+/- 14 days)
No study locations are listed for this record.
Plan to share: Undecided — Pseudonymized data, access provided to need to know basis, UK GPPR rules Aggregate results will be shared after they have been analysed.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bevacizumab · Faricimab