RecruitingInterventional

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

This study is for adults with blurry vision from a common eye problem caused by diabetes called vitreous haemorrhage. This happens when new blood vessels in the eye bleed, making it hard to see. Currently, patients often wait for the bleeding to clear, which can take months and delay laser treatment. Our study wants to find out if having surgery and laser treatment sooner (within 4 weeks) is a safer and better way to improve vision, help people recover faster, and mean fewer hospital visits compared to the usual waiting approach. We hope to understand if this new timing of treatment can offer a big improvement for people with this condition.

At a glance

Status

Recruiting

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Enrolment target

250

Start

02 Jan 2026

Estimated completion

31 Mar 2027

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

What is this study about?

This study is about an eye condition called 'vitreous haemorrhage' which can happen to people with diabetes. Imagine your eye as a camera; the back of it, called the retina, is like the film. In some people with diabetes, especially those with an advanced form called 'proliferative diabetic retinopathy', tiny new blood vessels can grow on this film. These new vessels are fragile and can bleed into the jelly-like substance that fills the eye, called the vitreous. This bleed makes your vision blurry, sometimes very suddenly.

Currently, if this happens, the usual approach is to wait to see if the blood clears up on its own. This waiting period can last for several months. Once the blood clears enough, doctors can then do laser treatment to stop new bleeds. However, sometimes the blood doesn't clear well enough, and surgery is needed to remove it. This surgery usually happens after a long wait and many hospital visits. In the past, early surgery wasn't common because the risks were thought to be high.

But now, eye surgery has become much safer and more advanced. So, this study wants to see if having surgery and laser treatment sooner (within 4 weeks of diagnosis) is a better idea. We want to find out if this quicker treatment helps people see better, recover their vision faster, and leads to fewer complications and hospital appointments compared to the standard 'wait and see' method.

Key takeaways

Compares early eye surgery to usual care for diabetes-related blurry vision.
Aims for faster vision recovery and fewer hospital visits.
Involves adults (18+) with diabetes and specific eye bleeding.
Participants are randomly assigned to one of two treatment groups.
Study runs from April 2025 to March 2028, across 25 NHS sites.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or over. You need to have either type 1 or type 2 diabetes. Importantly, you must be experiencing blurry or poor vision because of vitreous haemorrhage, which has developed due to proliferative diabetic retinopathy (PDR).

There are also some reasons why you might not be able to join. For example, if you've already had a specific type of eye surgery called 'pars plana vitrectomy' in the affected eye, or if your bleeding is due to something other than PDR. You also can't join if you have other serious eye conditions that might affect the study results, or if other health issues would make it hard for you to attend appointments or follow the study plan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have type 1 or type 2 diabetes?
Is your vision blurry due to bleeding in your eye (vitreous haemorrhage)?
Has this bleeding been diagnosed as being caused by advanced diabetic eye disease (PDR)?
Have you *not* had vitrectomy surgery in the affected eye before?
Are you able to attend appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. One group will receive the 'usual care,' which means waiting to see if the bleeding clears naturally before having laser treatment, and possibly surgery later if needed. The other group will have eye surgery and laser treatment within about 4 weeks of joining the study, followed by a check-up two weeks after their operation. After this, both groups will follow a similar care plan, meaning you'll still get any additional laser or other treatments if your doctor thinks you need them. All participants will have their vision and eye health checked every four months over a year. You'll also be asked to fill out questionnaires about your quality of life and take part in safety reviews. We'll also ask for a blood test when you start and finish the study. Remember, you are free to leave the study at any time.

Potential risks and benefits

If you join this study, you might benefit from knowing more about which treatment option is best for this condition. For those in the group receiving early surgery and laser treatment, there's a chance of recovering your vision faster, seeing better in the long run, having fewer complications, and needing fewer hospital visits. However, like any surgery, there are risks, such as the possibility of needing further treatments afterwards, infections, or the treatment not working as well as hoped. Modern surgical techniques have significantly reduced these risks. For those in the 'usual care' group, the benefit is that you avoid surgery if your bleeding clears up on its own. However, if it doesn't clear quickly, the delay might mean that eventual surgery is less effective or leads to more complications. You have the right to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NIHR Moorfields Biomedical Research Centre
City only
London, United Kingdom

Common questions

What is vitreous haemorrhage?

It's when small, fragile blood vessels in the eye, often caused by diabetes, bleed into the clear gel that fills your eyeball, making your vision blurry.

What is 'proliferative diabetic retinopathy'?

This is an advanced eye condition in people with diabetes where new, weak blood vessels grow at the back of the eye, which can easily bleed.

What does 'early surgery and laser treatment' mean in this study?

It means having a specific eye surgery and laser treatment within about 4 weeks of deciding to join the study, rather than waiting longer.

What if I change my mind during the study?

You are completely free to leave the study at any point, and your decision will not affect your future medical care.

Where in the UK is this study taking place?

This study is happening in 25 NHS hospitals across the UK, managed by Moorfields Eye Hospital in London.

How to find out more

Mohammed Rupawala

mohammed.rupawala@nhs.net +44 (0)207 253 3411 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.