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Could a laser switch reduce eye injections for severe Diabetes-Related vision loss?

NCT ID NCT06985706

Disease control Sponsor: Belfast Health and Social Care Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether people with severe diabetic macular oedema (swelling in the center of the retina) can switch from regular eye injections to a gentle laser once the swelling drops below a certain level. 264 adults with type 1 or type 2 diabetes will be randomly assigned to either continue injections alone or switch to laser. The goal is to see if the laser works just as well at preserving vision while reducing the need for repeated injections.

What this could mean

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

Active substance
anti-VEGF injections (ranibizumab, aflibercept, faricimab, brolucizumab) and subthreshold micropulse laser
What this could lead to
If successful, this could offer a way to reduce the number of injections needed for severe diabetic macular oedema by switching to laser when the swelling improves.
What could go wrong
This is a phase 3 trial, but it only includes people whose swelling has already improved with injections. The laser may not work as well as continuing injections, and results may not apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

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

Started

May 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adults (\>18 years) * Diabetes type 1 or type 2 * Presented with severe centre-involving (CI)-DMO (CRT ≥400 μm) * Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 μm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes Exclusion Criteria: * Causes of macular oedema other than DMO * DMO with CRT ≥400 μm * Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed) * Use of unlicensed anti-VEGFs (e.g. bevacizumab) * Inability, for any reason, to attend study visits * Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed) * Use of pioglitazone which cannot be stopped for the duration of the trial * Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks * Currently enrolled in a Clinical Trial of an Investigational Medical Product * Declined consent for participation

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe diabetic macular oedema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Birmingham and Midland Eye Centre

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Bristol Eye Hospital

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • Central Middlesex Hospital

    RECRUITING

    London, United Kingdom

  • Chelsea and Westminster Hospital

    NOT_YET_RECRUITING

    London, United Kingdom

  • East Surrey Hospital

    NOT_YET_RECRUITING

    Redhill, United Kingdom

  • Frimley Park Hospital

    RECRUITING

    Camberley, United Kingdom

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, United Kingdom

  • Hillingdon Hospital

    RECRUITING

    Uxbridge, United Kingdom

  • Hinchingbrooke Hospital

    NOT_YET_RECRUITING

    Huntingdon, United Kingdom

  • Hull Royal Infirmary

    NOT_YET_RECRUITING

    Hull, United Kingdom

  • James Cook Hospital

    RECRUITING

    Middlesbrough, United Kingdom

  • Kings College Hospital

    RECRUITING

    London, United Kingdom

  • Moorfields Eye Hospital

    RECRUITING

    London, United Kingdom

  • Queen's Medical Centre

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Royal Gwent Hospital

    NOT_YET_RECRUITING

    Newport, United Kingdom

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Singleton Hospital

    NOT_YET_RECRUITING

    Swansea, United Kingdom

  • Sunderland Eye Hospital

    RECRUITING

    Sunderland, United Kingdom

  • Sussex Eye Hospital

    NOT_YET_RECRUITING

    Brighton, United Kingdom

  • The Royal Hospitals Belfast

    RECRUITING

    Belfast, United Kingdom

  • Torbay Hospital

    NOT_YET_RECRUITING

    Torquay, United Kingdom

  • University Hospital Southampton

    NOT_YET_RECRUITING

    Southampton, United Kingdom