The Efficacy and Safety of Treatment with Intravitreal Ranibizumab in Patients with Branch Retinal Vein Occlusion.

This is a phase II randomised, single, dose, masked, multicentre trial to determine the efficacy of 0.5mg Ranibizumab intravitreal injections in the treatment of macular oedema secondary to BRVO over one year compared with standard laser grid. Patients eligible for the study will be randomised to receive an intravitreal injection of 0.5mg Ranibizumab or placebo for 6 months. Patients will be monitored for a further 6 months to see whether further treatment is required. Patients are evaluated by a masked investigator at 3 and 6 months to determine whether they require laser grid, the current standard treatment for this condition. The primary outcome will be the proportion of eyes showing an improvement of visual acuity by 10 letters on the LogMar chart for the treatment group versus the sham group at 52 weeks compared with baseline. The secondary outcome will be the change in baseline OCT central macular thickness between the treatment and the sham groups at 52 weeks. The tertiary objective will be the change in the mean capillary non-perfusion between the sham/laser and treatment groups at 52 weeks and the number of patients requiring grid macular laser.