A Phase 1 Dose Finding Study Of Intraocular Mitomycin-C Adjunct In Vitrectomy For Retinal Detachment And Proliferative Vitreoretinopathy (MORPH-1)
Lead Research Organisation:
UNIVERSITY COLLEGE LONDON
Department Name: Comprehensive CTU
Abstract
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. Our phase 1 study aims to demonstrate safety and efficacy of a novel formulation of a known anti-inflammatory drug and method of 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 the drug 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 drug, in addition to the standard eye operation. Patients will be monitored for 6-months after surgery to see the effects of the medication. This is an important study, as no treatment currently exists for stopping or treating PVR scar tissue in retinal detachment. We aim to deliver a new medication that will ultimately improve the vision outlook, reduce the number of eye operations and improve quality of life for our retinal detachment patients. We have conducted a contemporary survey with the national vitreoretinal society in the United Kingdom. Our vitreoretinal surgeon peers and colleagues have verified the unmet need for patients with PVR-complicated retinal detachment across the UK, and the majority would support the use of a new medication that is delivered locally within the eye tissue surfaces during vitrectomy surgery for retinal detachment to ultimately stop the scar tissue from coming back. Patients from Moorfields have helped us to develop this research. They will help us interpret the results and work with us to share our findings at hospital patient awareness days, medical and surgeon meetings, to our research partners, and through key public patient charity organisations.
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. Our phase 1 study aims to demonstrate safety and efficacy of a novel formulation of a known anti-inflammatory drug and method of 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 the drug 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 drug, in addition to the standard eye operation. Patients will be monitored for 6-months after surgery to see the effects of the medication. This is an important study, as no treatment currently exists for stopping or treating PVR scar tissue in retinal detachment. We aim to deliver a new medication that will ultimately improve the vision outlook, reduce the number of eye operations and improve quality of life for our retinal detachment patients. We have conducted a contemporary survey with the national vitreoretinal society in the United Kingdom. Our vitreoretinal surgeon peers and colleagues have verified the unmet need for patients with PVR-complicated retinal detachment across the UK, and the majority would support the use of a new medication that is delivered locally within the eye tissue surfaces during vitrectomy surgery for retinal detachment to ultimately stop the scar tissue from coming back. Patients from Moorfields have helped us to develop this research. They will help us interpret the results and work with us to share our findings at hospital patient awareness days, medical and surgeon meetings, to our research partners, and through key public patient charity organisations.
Technical Summary
Proliferative vitreoretinopathy (PVR) is an abnormal healing response with formation of scar tissue leading to retinal detachment in up to 20% patients. This is one of the greatest challenges for vitreoretinal surgeons as no pharmacological agents have yet proven to be effective in preventing PVR processes. Vitrectomy surgery is the main approach for PVR complications. Patients require many operations to remove the scar tissue but vision results are poor and do not meet patient expectations. We propose a dose-finding study (MORPH-1) to establish the optimal dose of intraocular formulation of a known anti-inflammatory drug for use in those patients with recurrent macula-OFF retinal detachment complicated by PVR, in order to reduce the adverse impact of PVR and enhance patient outcomes following retinal disruption. The drug has an established safety profile in other ophthalmology applications and our hypothesis is that the drug can prevent PVR scar tissue formation in retinal detachment, and promote stable and secure retinal reattachment.
