Title: Assessing Impact and Directing treatment in patients with Uveitic Macular Oedema (AID UMO) Study
Funder: Health Education England

Abstract: Scientific abstract Background: Macular oedema (MO) is the leading cause of sight-loss in patients with intraocular inflammation (uveitis). Until recently it has not been possible to measure uveitic MO accurately, contributing to a lack of evidence as to which treatments are effective in treating this condition, and their relative benefits. The advent of a novel light-based imaging technique called optical coherence tomography (OCT) enables early detection, characterization and monitoring of MO and has been proposed as an ideal sensitive objective marker that can be used as an outcome measure in trials of efficacy. There is currently no consensus regarding which outcome measures should be used in uveitis clinical trials, and in most cases these outcome measures are selected by one or more expert clinicians without regard to other essential stake-holders such as patients, carers or policy makers. There is therefore an urgent need for a consensus core outcome set for use in uveitis. Aims: This proposal comprises both Evidence Synthesis and Core Outcome Set development components to investigate the following areas which are of primary importance to patients with uveitis: (1) to establish the evidence base for the safety and efficacy of currently available treatments in the management of uveitic MO; (2) to establish the use of OCT in uveitic MO and the association of OCT parameters with visual function; and (3) to define a consensus-based core-outcome set that should be gathered in all clinical trials of uveitis, and which has value to all stake-holders. Plan of investigations: WP1: Systematic/Cochrane Review of Pharmacological Therapies for the Treatment of Uveitic MO WP2: Systematic Review of the Use of OCT in Uveitic MO. WP3: Development of Core Outcome Set in Patients with Uveitis with and without Uveitic MO Summary of potential benefits to the NHS: Uveitic MO is a major cause of blindness in the working-age population. Currently there is wide-variation in treatment reflecting both the relative paucity of robust primary data, and a lack of national guideline or consensus statement. Our development of a systematic review on the Pharmacological Treatment of Uveitic MO within the Cochrane Eyes and Vision Group will provide a clear reference point for UK specialists and is likely to lead to increased standardization of UK practice in line with current evidence. This is timely due to the advent of novel local therapies which have been approved by NICE for other forms of MO, but whose role in Uveitic MO is not yet established. Our systematic review of the use of OCT in Uveitic MO and its association with measures of visual function will contribute to the emerging discussion as to whether OCT should be used as an outcome measure in effectiveness trials. Finally our broader consideration of outcome measures in uveitis (both in those with UMO and without UMO) will for the first time provide a core outcome set that has value to all stake-holders and can be used in all efficacy trials in uveitis. This has the potential to profoundly enhance evidence synthesis by reducing heterogeneity between trials, reduce outcome-reporting and improve the statistical power of the resulting meta-analysis. Research questions We aim to answer the following questions:1) What is the current level of evidence to direct treatment decisions in uveitic MO? 2) What is the association of OCT parameters with visual function in uveitic MO? 3) What are the outcome measures in uveitis that have value to all stake-holders?

Lay abstract: Macular oedema (MO) describes the accumulation of fluid in the retina (the light-sensitive inner-lining of the eye) in the area that provides our central vision (the 'macula'). MO is the leading cause of sight-loss in people with inflammation inside the eye ('uveitis'). Numerous studies have assessed treatments for uveitic MO but they vary in quality and use measures of success that have been decided by the doctor rather than by the patient. We will evaluate these studies and then involve patients, carers and policy-makers to reach a consensus as to how to measure treatment 'success' in uveitis.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: EYE