CompletedPhase 2

The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema

United Kingdom10 participantsStarted 2012-05-01

Plain-language summary

Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment of a variety of retinal diseases. This study addresses a condition which affects a large number of our patients in whom the investigators face difficult management decisions. These patients with uveitis are severely disabled with visual loss related to cystoid macular oedema (CMO) and few options remain when standard treatment has either failed or is contraindicated. The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be more effective in improving quality of life by reducing macular thickening and restoring visual function.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cystoid macular oedema (CMO) from non-infectious uveitis:
. Best corrected visual acuity in the study eye must be between 69 and 35 ETDRS letter score at 4m (Snellen equivalent of 6/12-6/60) within 10 working days of enrolment.

Exclusion criteria

. Other causes of macular oedema e.g. diabetic macular oedema etc.
. Presence of an ocular disease that in the opinion of the investigator is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates).
. Evidence of irreversible central visual loss
. Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of patients in whom, by consensus, no further treatment is required.

Timeframe: Data will be collected at every patient visit which will take place every 4-5 weeks, and analysed at 12 months follow-up

Change in CRT as measured by Spectralis spectral domain OCT.

Timeframe: at baseline visit then at 6 and 12 months.

Trial details

NCT IDNCT01564108

SponsorMoorfields Eye Hospital NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Uveitis Related Cystoid Macular Edema trials