A Randomised Controlled Trial Comparing the Two Protocols of Treatment of Intravitreal Bevacizumab for Neovascular Age Related Macular Degeneration (Bemoc Trial)

Abstract

Purpose: : A prospective randomised controlled trial assessing the efficacy and comparing the two protocols of treatment with intravitreal Bevacizumab in patients with minimally classic and occult choroidal neovascularisation (CNV) secondary to age related macular degeneration (AMD), a 6 months interim analysis

Methods: : 100 patients were randomised into two groups and enrolled into this prospective study. First group had Bevacizumab administered once a month for three consecutive months and thereafter as needed (LD: loading dose). Second group had Bevacizumab administered as needed after the first injection (PRN: pro re nata). Evaluation consisted of a complete ophthalmic examination, including Early Treatment Diabetic Retinopathy Study visual acuity testing, ophthalmoscopy and optical coherence tomography at baseline and follow up visits every six weeks. Treatment consisted of pars plana injection of 1.25 mg of Bevacizumab /0. 05 ml. In both groups the retreatment criteria were the presence of sub retinal fluid, new haemorrhage, and persistent or recurrent macular oedema.

Results: : At the 6 month follow up, mean visual acuity improved by 3.43 (p < .01) letters in the loading group and 1.16( p =.05) letters in PRN group. 22% patients in the loading group compared with the 16% in the PRN group gained 10 or more letters. Mean macular thickness decreased by 40.3(p < .01) microns .in the LD group and 76.8(p < .001) in the PRN group. One case of retinal pigment epithelial (RPE) tear was noticed. One patient had myocardial infarction and was withdrawn from the study

Clinical Trial: : www.ISRCTN.org 12980412

Keywords: age-related macular degeneration • vascular endothelial growth factor • choroid: neovascularization