Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

Phase 1 Dose Finding Study of Intraocular Mitomycin C adjunct in Vitrectomy for Retinal Detachment and Proliferative Vitreoretinopathy

Funder NIHR (part of DHSC)
Recipient organisation NIHR Moorfields Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Mar 2028

In plain English

AI plain-English summary

A single dose of the chemotherapy drug mitomycin C, injected into the eye during retinal detachment surgery, is being tested to see if it can stop a blinding scarring reaction that currently has no treatment. This matters because proliferative vitreoretinopathy (PVR) is the most common reason retinal detachment surgery fails. After the initial repair, an over-aggressive healing response creates scar tissue that pulls the retina off again, forcing patients into multiple repeat operations that often still result in poor vision. Decades of clinical trials have failed to find any drug that prevents this scarring. If this dose-finding study identifies a safe and potentially effective dose of mitomycin C, it would open the door to a larger trial testing whether a single intraoperative injection can dramatically reduce re-detachment rates. Success would mean fewer repeat surgeries, lower healthcare costs, and better long-term vision for the roughly 50 patients in this study and potentially thousands more each year in the UK alone. The research also collects fluid samples to measure which scarring-related immune signals the drug suppresses, providing mechanistic insight into how PVR develops.

View original technical description
Proliferative vitreoretinopathy (PVR) is an abnormal and prolonged healing response to retinal injury (retinal detachment, post-retinal detachment surgery) characterised by: pre/subretinal membrane formation; retinal gliosis and retinal shortening, retinal pigment epithelium cell proliferation; and increased glial (mainly Mueller cells), fibroblast and inflammatory cell (macrophage, lymphocyte) activity, leading to tractional retinal holes/breaks and further retinal detachment and multiple costly eye operations suffered by patients. Despite previous large clinical trials of multiple candidate drug therapeutics, no proven adjunctive treatment currently exists to prevent or reduce PVR formation in retinal detachment. Overall objective is to undertake a dose-finding study using the Continual Reassessment Method to define a safe and potentially efficacious mitomycin C (MMC) dose for patients with PVR grade C related rhegmatogenous retinal detachment. We aim to recruit 50 patients for this purpose. Aim is to explore mechanistic efffects of MMC in retinal detachment surgery. Aqueous and vitreous fluid samples will be taken during operations,and sent for laboratory analysis with panels of cytokines.We will examine assay results for change,and significant reductions of PVR-related cytokines in the MMC-groups compared to baseline/pre-surgery. Other secondary outcomes include visual acuity, laser flare photometry, imaging and electrophysiology assessments.

Researchers

James Bainbridge (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase 1 Dose Finding Study of Intraocular Mitomycin-C adjunct in Vitrectomy for Retinal Detachment and Proliferative Vitreoretinopathy (MORPH-1)
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Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (acronym CLARITY)
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Original classification

Genomic Discovery and Therapeutics

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.