Visual impairment due to VEGF driven Macular Oedema
Research type
Research Study
Full title
A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME)
IRAS ID
131355
Contact name
Philip Hykin
Contact email
Sponsor organisation
Novartis
Eudract number
2012-005418-20
Clinicaltrials.gov Identifier
Research summary
This is a 12 month study comparing the effect of ranibizumab (Lucentis) with sham (no treatment) in patients with visual impairment due to a condition called macular oedema. Macular oedema describes swelling in the central part of the retina, which is the light-sensing layer at the back of the eye. This study will specifically examine patients with macular oedema not caused by diabetes or retinal vein occlusion. There are currently no approved treatments for this patient group. As ranibizumab blocks a protein called VEGF, and is effective in treating macular oedema caused by diabetes or retinal vein occlusion, it is hoped this treatment will improve or limit vision loss in this patient group. Patients 18 years and older will be included in this study with a target number of patients in the UK 16 over approx. 8 sites. Patients will be asked to attend the clinic for at least 15 visits over the 12 month study period
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0254
Date of REC Opinion
18 Jul 2013
REC opinion
Favourable Opinion