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Contact Information:

Mr Rodrigo Anguita Henriquez
r.anguitahenriquez@nhs.net


Dr Mohammed Rupawala
mohammed.rupawala@nhs.net


Miss Louisa Wickham
louisa.wickham1@nhs.net


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Be Part of Research - Trial Details - A nationwide clinical trial for patients with the eye condition vitreous haemorrhage due to proliferative diabetic retinopathy investigating whether early eye surgery and laser treatment is a safe and better option for improving visual outcomes than the current standard of care
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A nationwide clinical trial for patients with the eye condition vitreous haemorrhage due to proliferative diabetic retinopathy investigating whether early eye surgery and laser treatment is a safe and better option for improving visual outcomes than the current standard of care

Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Adults with type 1 or type 2 diabetes presenting with visual impairment due to vitreous haemorrhage secondary to proliferative diabetic retinopathy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The most common cause of severe vision loss in people with diabetes is proliferative diabetic retinopathy (PDR). This condition affects about 3% of the UK population with diabetes, most being of working age. In PDR, the eye grows new blood vessels on the retina. The retina needs to be treated urgently by laser so that these blood vessels disappear or become inactive. If left untreated, these blood vessels can bleed into the vitreous region of the eye (termed vitreous haemorrhage [VH]) causing a sudden drop in vision and a delay to laser treatment. Nearly 50% of patients who develop PDR may still experience VH within 5 years despite good laser treatment. VH due to PDR is a global health problem that needs a new treatment strategy. The current Standard-of-Care (SoC) for patients involves:
1. A period of waiting for the bleeding to clear naturally, which usually lasts months.
2. Once the bleeding resolves, repeated laser treatments to prevent rebleeding.
3. If the blood does not clear sufficiently to apply laser treatment (about 20% of cases), the vitreous gel with blood is removed surgically (called vitrectomy) with laser treatment applied at the time of surgery. This procedure is typically offered after a long period of observation and several hospital appointments.
Clinical trials in the 1980s showed that patients with dense VH who underwent vitrectomy within 6 months had greater vision improvement, however, this approach was not recommended due to the risks of surgery. Since then, techniques and equipment for performing vitrectomy have advanced significantly reducing the risks of surgery.
This study aims to investigate whether for patients with VH due to PDR, early vitrectomy with laser treatment applied at the time of surgery is a safe and better option for improving visual outcomes, allowing faster visual rehabilitation, and reducing hospital appointments than the current SoC.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

02 Jan 2026 31 Mar 2027

The study involves patients being randomly assigned to one of two treatment groups. One group will undergo SoC as described in the background. The other group will have surgery + laser treatment within 4 weeks of joining and a safety visit 2 weeks after their surgery + laser appointment. They will then follow a SoC pathway so if they require additional laser treatments or other interventions this will be provided. All patients on the trial will be followed up every 4 months over a 12-month period where they will undergo vision and optical function assessments, and take part in questionnaires to understand their quality of life and patient safety reviews. On entering and exiting the trial all patients will also undergo a blood test. Patients will be free to exit the trial at any point if they wish to do so.


Adults (aged 18 years and above) who have diabetes type 1 or 2 and vision impairment due to a diagnosis of VH due to PDR.

You can take part if:



You may not be able to take part if:


1. Previous surgery: history of PPV in the affected eye2. Non-PDR VH caused by conditions unrelated to PDR3. Other eye conditions: significant co-existing ocular pathology that might interfere with outcomes (e.g., advanced glaucoma, endophthalmitis)4. Systemic conditions: any systemic condition preventing follow-up or compliance with the trial protocol


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR Moorfields Biomedical Research Centre
    Moorfields Eye Hospital NHS Foundation Trust 162 City Road
    London
    EC1V 2PD

This study will provide patients and the clinical community with information on the risk-to-benefit ratio of early vitrectomy for VH due to PDR. Participants assigned to the early surgery + laser treatment group and continuing for the full follow-up duration of 12 months would potentially benefit from faster visual recovery, improved visual outcomes, fewer complications, and reduced burden of outpatient visits and treatments compared to the current standard of care. However, the risks of participating are that, despite early surgery, patients may require postoperative intervention due to complications (e.g., detachment of the retina), infection, or limited response to the treatment. As with any surgery there will also be an intraoperative risk. Intra- and post-operative risks are now significantly reduced due to improved surgical techniques. For those in the standard-of-care arm, the benefits will be that, if the VH resolves spontaneously or early laser treatment is effective, then patients will not need to be exposed to the risks of surgery. As this is the current patient care pathway, the risks of being in this arm are the same as the current risks of care. The delay to surgery for those whose VH does not spontaneously resolve or does not respond well to early laser treatment may mean the surgery (>4 months) is less effective or results in further complications. This will be explored in this study.

Dr Mohammed Rupawala
mohammed.rupawala@nhs.net


Miss Louisa Wickham
louisa.wickham1@nhs.net


Mr Rodrigo Anguita Henriquez
r.anguitahenriquez@nhs.net



The study is sponsored by Moorfields Eye Hospital NHS Foundation Trust and funded by National Institute for Health and Care Research; Medical Research Council (MRC).




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Read full details for Trial ID: ISRCTN17116576

Or CPMS: 61991

Last updated 24 October 2025

This page is to help you find out about a research study and if you may be able to take part

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