Intravitreal ranibizumab for persistent diabetic vitreous haemorrhage: a randomised, double-masked, placebo-controlled feasibility study.

PURPOSE: To determine the feasibility of a definitive study of intravitreal ranibizumab to promote the clearance of persistent diabetic vitreous haemorrhage and thereby avoid vitrectomy. METHODS: This randomised, double-masked, placebo-controlled feasibility study recruited 24 participants with persistent diabetic vitreous haemorrhage listed for pars plana vitrectomy. Participants were randomised to a single 0.5-mg intravitreal ranibizumab injection or a single subconjunctival saline injection. The primary outcome measure was the number of participants requiring pars plana vitrectomy at week 7. RESULTS: Eight of 12 participants (66.7%) in the ranibizumab group required vitrectomy at week 7 versus 12 of 12 (100%) in the placebo group (absolute risk reduction 33.3%, 95% confidence interval 2.1-70.7%; p = 0.09). One additional eye in the ranibizumab group required vitrectomy by 12 months. Mean visual acuity letter score at 12 months was 72.7 ± 12.3 in the ranibizumab group and 75.1 ± 10.1 in the placebo group. Safety was similar across groups. CONCLUSION: Intravitreal ranibizumab may reduce the likelihood of proceeding to vitrectomy in patients with persistent, dense diabetic vitreous haemorrhage. Further studies appear feasible and justified.