AMOUR
Research type
Research Study
Full title
Aflibercept (Eylea®) for macular oedema associated with underlying Retinitis Pigmentosa (AMOUR)
IRAS ID
189957
Contact name
Michel Michaelides
Contact email
Sponsor organisation
Moorfields Eye Hospital
Eudract number
2015-003723-65
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Inherited retinal disease is the second commonest cause of visual loss in childhood and the commonest cause of visual loss in the working age population. Retinitis Pigmentosa (RP) is the commonest inherited retinal disorder with an incidence of 1 in 3,000. There are no cures currently for RP. Patients with RP experience two complications for which there are potential treatments – cataracts and cystoid macular oedema (CMO). Approximately 20% of patients with RP develop CMO which causes significant central visual loss and disability. Several different treatments for CMO have been employed including laser therapy, topical trusopt, oral acetazolamide (Diamox), peri-ocular and intravitreal steroids, and intravitreal anti-VEGF agents. The current mainstay of treatment is topical or oral carbonic anhydrase inhibitors, however, these are sometimes ineffective and/or have intolerable side-effects that warrant their discontinuation. The vast majority of the published literature is retrospective and thereby inherently limited and often involves small numbers of participants and short duration of follow-up. We wish to look at the safety and efficacy of a drug called Eylea, for its use in RP associated CMO. This drug is already licensed for use within the NHS for CMO secondary to other conditions including macular degeneration, diabetic eye disease and vein occlusion. Eylea acts by decreasing vascular permeability (leakage) from disrupted endothelial cells and is administered as an injection into the eye. Each patient will receive one injection per month for 3 months followed by an injection every 4 – 12 weeks (depending on patient response) until the study finishes at 12 months. Safety and efficacy will be looked at using end points such as macular thickness, visual acuity and adverse events. The results of this study would be used to guide further investigation via a multi-centre larger study.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1910
Date of REC Opinion
13 Nov 2015
REC opinion
Favourable Opinion