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Evaluation of results 1 year following short-term use of ranibizumab for vitreous hemorrhage due to proliferative diabetic retinopathy.

Vitreous hemorrhage from proliferative diabetic retinopathy (PDR) can cause vision loss and preclude panretinal photocoagulation (PRP).1 The DRCR.net investigated whether intravitreal ranibizumab compared with intravitreal saline had a beneficial effect on the vitrectomy rates of eyes with vitreous hemorrhage from PDR precluding complete PRP. Eyes were randomly assigned to 0.5mg ranibizumab (N=125) or saline (N=136), which were injected into the vitreous, at baseline, 4 and 8 weeks.2 The primary endpoint was assessed at 16 weeks, for safety purposes participants were followed for 52-weeks. It should be noted, after 16-weeks, participant’s management was at investigator’s discretion. 
 
As previously reported, by the 16-week endpoint the cumulative probability of vitrectomy was 12% for eyes assigned to ranibizumab compared with 17% for saline (difference 4%, 95% confidence interval [CI]: −4% to +13%),2 suggesting little likelihood of a clinically important difference. The study did not address whether ranibizumab or saline injections were superior to observation alone. Previously reported secondary outcomes suggested a short-term positive biologic effect of ranibizumab compared with saline: (1) the ability to complete PRP without vitrectomy by 16 weeks was 44% with ranibizumab versus 31% with saline group (P=0.05), (2) mean visual acuity improvement from baseline to 12 weeks was 22±23 letters with ranibizumab versus 16±31 letters with saline (P=0.04), and (3) recurrent vitreous hemorrhage within 16 weeks occurred in 6% of eyes with ranibizumab compared with 17% with saline (P=0.01). No short-term safety concerns were noted. The objective of this report is to present the one-year follow-up results to the original study.