The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema (NCT01564108) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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.
✕. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
✕. History of cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial.
What they're measuring
1
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
2
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