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Can a new eye injection preserve vision in south asians with diabetes?

NCT ID NCT07753616

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether faricimab, an eye injection, can improve vision and reduce swelling in South Asian patients with diabetic macular edema (DMO), a complication of diabetes that can lead to blindness. Previous studies mostly included Caucasian or East Asian participants, leaving a gap for South Asians who have higher rates of diabetes and DMO. The study will follow 120 UK-based South Asian adults for up to 88 weeks, using a treat-and-extend approach where the time between injections is adjusted based on response. The goal is to see if faricimab provides meaningful vision gains, durable control of retinal swelling, and a safe profile in this specific population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Faricimab (intravitreal anti-VEGF injection)
What this could lead to
If successful, this could confirm faricimab as an effective treatment for diabetic macular edema in South Asian patients, potentially leading to better vision outcomes and longer-lasting effects with fewer injections.
What could go wrong
This is a phase 4 study with a relatively small sample size (120 participants), and results may not generalize to all South Asian populations. As with any eye injection, there are risks of infection, inflammation, or increased eye pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All subjects must meet all of the following inclusion criteria to participate: 1. Patients who self-identify themselves as of South Asian origin. Including Indian, Pakistani, Bangladeshi and Sri Lankan. 2. Adults aged ≥18 years at time of consent. 3. Documented diagnosis of type 1 or type 2 diabetes mellitus. 4. Best-corrected visual acuity (BCVA) of 20-73 ETDRS letters, corresponding approximately to 6/12 to 6/120 Snellen (metres) in the study eye. 5. 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. 6. Decreased visual acuity attributable primarily to DMO. 7. Both eyes may be eligible; however, the eye with the higher CST will be designated as the study eye. 8. 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. 9. Ability and willingness to provide written informed consent and comply with all study procedures and follow-up. Exclusion Criteria: All subjects meeting any of the following exclusion criteria at baseline will be excluded from participation: <!-- --> 1. Untreated diabetes mellitus, or initiation of oral or injectable anti-diabetic therapy within 3 months prior to Day 1. 2. Uncontrolled blood pressure: systolic \>180 mmHg or diastolic \>100 mmHg at rest. 3. Pregnant or breastfeeding women, or intention to become pregnant during the study period. 4. Pan retinal photocoagulation (PRP) or macular laser in the study eye within 3 months prior to Day 0. 5. Intraocular or periocular corticosteroid therapy in the study eye within 6 months prior to Day 0. 6. Previous treatment with Fluocinolone acetonide (Iluvien) in the study eye. 7. Active proliferative diabetic retinopathy in the study eye. 8. Active ocular or periocular infection, or active intraocular inflammation, in the study eye. 9. 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 10. Previous vitrectomy in the study eye. 11. Cataract surgery or any other intraocular surgery in the study eye within 3 months of baseline if followed by macular oedema which can confound the DMO diagnosis. Planned cataract surgery in the study eye once treatment commenced and after the loading dose, is allowed as per clinician discretion. 12. Known hypersensitivity to faricimab or any of its excipients. 13. Any systemic condition, abnormal laboratory finding, or concomitant therapy that, in the opinion of the investigator, may compromise patient safety or the validity of study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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