LEAVO (Version 1.0)
Research type
Research Study
Full title
A Multicentre Phase III Double-masked Randomised Controlled Non-Inferiority Trial comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion (CRVO).
IRAS ID
137864
Contact name
Philip Hykin
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Eudract number
2014-000272-26
Research summary
The retina has a blood supply of arterioles and capillaries that supply oxygen and nutrients to the retina. Blood drains from the retina and leaves the eye through the central retinal vein. Approximately 6000 patients per annum in England and Wales are affected by fluid accumulating in the macula (macular oedema [MO]) secondary to blockage of the central retinal vein (CRVO). Until 3 years ago no treatment improved visual acuity in MO due to CRVO. The dexamethasone intravitreal implant was recommended by NICE in 2011, although it has limited efficacy and significant side effects. More recently Ranibizumab was NICE recommended (2013)and Aflibercept has received a positive TAG (2014). Both are likely more effective in improving visual function in patients with MO due to RVO and cause relatively few side effects. Aflibercept may have longer duration of action than ranibizumab but there is no data on the comparison for this condition. Bevacizumab, similar to ranibizumab, is unlicensed for use in the eye, but commonly used ‘off label’ and has been shown to be as good as ranibizumab for wet macular degeneration, and is significantly cheaper. Its use in MO due to RVO would result in very significant NHS cost savings. However, NICE requires robust clinical trial data to support its routine use for this condition in the NHS. This trial will determine whether bevacizumab and aflibercept are as effective as ranibizumab in improving visual function in MO due to CRVO and sufficiently cost effective to merit their use. This trial will randomise 459 patients with MO due to CRVO 1:1:1 to bevacizumab vs aflibercept vs ranibizumab and follow them for 2 years. The research will take place in approximately 40 Ophthalmology Centers in the UK and will be managed by the King’s Clinical Trials Unit.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1043
Date of REC Opinion
4 Sep 2014
REC opinion
Further Information Favourable Opinion