RecruitingPhase IInterventional

A study to explore the best dose of mitomycin-c inside your eye during retinal detachment surgery

This study investigates a common anti-scarring medicine called Mitomycin-C (MMC) to see if it can improve outcomes for people having eye surgery for a severe type of retinal detachment. Sometimes, after a retina detaches, scar tissue can form inside the eye, making it detach again and leading to poor vision. This condition is called proliferative vitreoretinopathy (PVR). MMC has been used for other eye problems to prevent scarring. This research aims to find the safest and most effective dose of MMC to put directly into the eye during surgery for patients at high risk of PVR. It hopes to prevent further detachments and improve overall vision after surgery.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

University College London

Enrolment target

Start

01 Jun 2025

Estimated completion

01 Feb 2027

Proliferative vitreoretinopathy in rhegmatogenous retinal detachment

What is this study about?

Imagine your eye like a camera, with a thin layer at the back called the retina, which is like the film. It's essential for you to see clearly. Sometimes, a hole or tear can appear in the retina, causing it to come away from the back of the eye, a condition known as retinal detachment. This needs surgery to fix.

For some people, after their retina is reattached, scar tissue can grow on its surface. This scarring, called proliferative vitreoretinopathy (PVR), can pull on the retina, causing it to detach again. When this happens, it often means more operations and can lead to poor vision. Preventing this scarring has been a challenge for doctors.

This study is looking at a medicine called Mitomycin-C (MMC), which has been used in eye care for many years to stop scarring after other types of eye surgery. It's a low-cost medicine already used safely around the world. The researchers want to find the best and safest amount, or 'dose', of MMC to put inside the eye during surgery for patients with retinal detachment who are at high risk of developing this scarring. The goal is to help more people have a successful outcome from their surgery and better vision.

Key takeaways

This study aims to find the safest dose of Mitomycin-C (MMC) for retinal detachment surgery.
MMC may help reduce scar tissue (PVR) that causes the retina to detach again.
It's for people with a specific type of complex retinal detachment.
Participation involves receiving MMC during your standard eye surgery.
Study visits align with your usual post-surgery check-ups.
The goal is to improve vision outcomes and reduce the need for more surgeries.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be able to take part if you have a specific type of retinal detachment where scar tissue (PVR grade C) has already formed, or if your retina has detached again. You will need to have surgery where silicone oil is used inside your eye.

You must be able and willing to sign a consent form and attend all the follow-up appointments required by the study. If you could become pregnant, you'll need a negative pregnancy test before surgery and agree to use contraception throughout the study.

There are also some reasons why you might not be able to join. These include having had a bad reaction to Mitomycin-C before, or if you have certain other serious eye conditions like advanced glaucoma or uncontrolled eye infections. It's also not suitable if you are pregnant, planning to become pregnant during the study, have given birth recently, or are breastfeeding.

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?
Have you been diagnosed with retinal detachment that also has significant scar tissue (PVR Grade C), or a recurring detachment?
Are you scheduled for eye surgery where silicone oil will be used?
Can you attend all follow-up appointments related to your surgery and the study?
If you could get pregnant, are you able to use contraception throughout the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study medicine, Mitomycin-C (MMC), during your standard eye operation. This is on top of the usual surgery you would have. The researchers will start with a very low dose of MMC and gradually increase it for later participants to find the safest and most effective amount.

After your surgery, you will have a series of follow-up visits. You'll have an appointment the day after surgery, then weekly visits for three weeks. For the first three months after surgery, you'll have appointments every two weeks. All these follow-up visits and care are part of the standard practice for retinal detachment, so taking part in the study shouldn't add extra appointments to your schedule. The study is expected to run from November 2024 to January 2028.

Potential risks and benefits

The main benefit of taking part is that the study medicine, Mitomycin-C, could help reduce scarring in your eye, potentially leading to better vision and fewer repeat surgeries. While MMC has been used in eyes for a long time, its use directly inside the eye for this specific problem has been studied in only a small number of people. Those small studies showed no major safety issues. However, there's always a risk that in a larger group of people, side effects could be more common. The study will start with a very low dose to carefully monitor safety. You are free to withdraw from the study at any time without affecting your medical care.

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, England

Common questions

What is retinal detachment?

It's when the retina, the light-sensitive layer at the back of your eye, pulls away from its normal position, which can cause blurry vision or vision loss.

What is PVR?

PVR, or Proliferative Vitreoretinopathy, is when scar tissue forms on the retina after a detachment, which can pull on the retina and make it detach again.

What is Mitomycin-C?

It's a medicine that has been used in eye care for over 30 years to help prevent scarring after eye surgery.

Will I have more hospital visits if I join the study?

No, the study visits are designed to fit in with the standard follow-up care you would usually receive after retinal detachment surgery, so it shouldn't add extra appointments.

Who is paying for this research?

The Medical Research Council in the UK is funding this study.

How to find out more

Jessie Barry

cctu.morph@ucl.ac.uk +44 (0)20 3108 4933 Official trial record

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