MORPH-1
Research type
Research Study
Full title
A Phase 1/2 Dose Finding Study of Intraocular Mitomycin-C adjunct in Vitrectomy for Retinal Detachment and Proliferative Vitreoretinopathy (MORPH-1)
IRAS ID
1010526
Contact name
Mahiul Muqit
Contact email
Sponsor organisation
University College London - Comprehensive Clinical Trials Unit
ISRCTN Number
ISRCTN21354914
Research summary
The aim of this study is to investigate the potential benefit of a commonly used anti-inflammatory treatment to improve the
outcome of surgery in eyes with "retinal detachment." The retina is a thin layer, which lines the inside of the eye. It is
sensitive to light (like the film in a camera) and is necessary for vision. If a hole or tears develop in a retina, it can become
detached. Retinal detachment is the most common eye emergency. For 1 in 5 patients the detached retina can develop
scar tissue on its surface, a complication termed "proliferative vitreoretinopathy" (PVR). This PVR scar tissue pulls on the retina preventing the holes or tears from being repaired by standard surgery. The scar tissue increases your risk of the retina detaching again, and requires more operations to resolve the problem. Multiple surgeries to remove the scar tissue often results in poor vision outcomes that do not meet patient's expectations. Efforts to stop and treat PVR scar tissue formation have so far proved unsuccessful.
Mitomycin C (MMC) has been used in ophthalmology for over 30 years, with evidence to show its ability to stop scarring
after eye surgery. This low-cost drug is currently used routinely around the globe to treat patients for other eye problems,
by applying MMC-soaked mini-sponges to the external surface of the eye. Our phase 1/2 study aims to demonstrate safe and
potentially efficacious MMC treatment by direct application to the internal surface of patient's eye with retinal detachment,
at high risk of PVR. Researchers at University College London and Moorfields Eye Hospital will undertake a study of approximately 50 patients
to define the most appropriate and safest dose of MMC in patients with retinal detachment. We will treat only patients who
have a diagnosis of repeated retinal detachment complicated by scar tissue, and they will receive the MMC, in addition to
the standard eye operation.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0211
Date of REC Opinion
4 Feb 2025
REC opinion
Further Information Favourable Opinion