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Abdhish Bhavsar, Diabetic Retinopathy Clinical Research Network (DRCR.net); A Randomized Trial Evaluating Intravitreal Ranibizumab or Intravitreal Saline for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2013;54(15):205.
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To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for eyes with vitreous hemorrhage from proliferative diabetic retinopathy (PDR).
Eligible eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation (PRP) completion. Eyes were randomly assigned to 0.5-mg intravitreal ranibizumab (N = 125) or intravitreal saline (N = 136) at baseline, 4, and 8 weeks. Injections were deferred at 4 and 8 weeks if vitrectomy had already been performed or the hemorrhage had cleared such that complete PRP could be given (or it was determined that complete PRP was already given). Study participants and all study personnel were masked to treatment assignment. At each visit the study eye was assessed to determine whether vitrectomy was indicated based on protocol guidelines.
The cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab versus 17% with saline (hazard ratio 0.74, 95% confidence interval (C.I.) 0.38-1.43, P = 0.37). The treatment group difference in the cumulative probability of vitrectomy was 4% (95% C.I. (-4%, 13%)). The cumulative probability of complete PRP without vitrectomy by 16-weeks was 44% and 31% respectively (P = 0.05). The mean (±SD) visual acuity improvement from baseline to 12 weeks was 22±23 letters and 16±31 letters respectively (P = 0.04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17% respectively (P = 0.01). One eye developed endophthalmitis after a saline injection. Eight eyes (6%) in the ranibizumab group and 9 eyes (7%) in the saline group had a traction retinal detachment (P>0.99). Rhegmatogenous retinal detachments were reported in one eye (<1%) in the ranibizumab injection group and 2 eyes (2%) in the saline injection group. One additional eye in the ranibizumab injection group reported a combination of traction and rhegmatogenous retinal detachment.
While the study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR, short term secondary outcomes including visual acuity improvement, increased PRP completion rates, and reduced recurrent hemorrhage rates suggest biologic activity of ranibizumab without an increased risk of traction retinal detachment.
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