The REVOLUTIONARY trial: A pilot study to assess the efficacy, durability, and safety of combination ranibizumab + peripheral scatter laser for macular edema secondary to branch retinal vein occlusion associated with peripheral nonperfusion on ultrawide-field angiography.

Abstract

Purpose: To determine the efficacy, durability, and safety of combination intravitreal ranibizumab plus peripheral scatter laser in patients with macular edema secondary to branch retinal vein occlusion associated with peripheral retinal nonperfusion on ultrawide-field fluorescein angiography. Methods: A 12-month, randomized, controlled, prospective, single center phase I/II study of 12 treatment-naive eyes of 12 patients with visual impairment secondary to macular edema secondary to branch retinal vein occlusion associated with peripheral nonperfusion on ultrawide-field fluorescein angiography. Patients were randomized in 1:1 fashion to study and control groups. Patients in the study group received angiography-guided peripheral scatter laser treatment at baseline. All patients received six monthly intravitreal injections of ranibizumab followed by six months of observation with pro re nata treatment with ranibizumab if prespecified visual acuity or optical coherence tomography criteria were met. Results: At the 6-month primary outcome, both groups had significant improvement in mean change in best-corrected visual acuity (treatment: +16.8 letters v/s control +14.5 letters) and reduction in central foveal thickness (treatment: -207 μ m v/s control -241 μ m). Both groups also had an improvement at 12 months in mean change in best-corrected visual acuity (treatment: +19.1 letters v/s control +15.3 letters) and reduction in central foveal thickness (treatment: -282 μ m v/s control -281 μ m). The differences between groups were not statistically significant. In the 6-month observation period, the REVOLUTIONARY group had a statistically-significant fewer number of retreatments (median of 1 in the treatment group v/s 2.5 in the control group p=0.03), and there was a trend in the reduction of patients needing retreatment (67% in the treatment group v/s 100% in the control group, p=0.14). Conclusion: This pilot study suggests safety and durability of combination ranibizumab + angiography-guided peripheral scatter laser in treatment-naive patients with macular edema secondary to branch retinal vein occlusion and peripheral nonperfusion on ultrawide-field fluorescein angiography. Further investigation is warranted to demonstrate the efficacy and long-term benefit of this treatment strategy.