Prospective, randomized, multicenter, open label, phase II / III study to assess efficacy and safety of ranibizumab 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus and PRP in monotherapy in the treatment of patients with high risk proliferative diabetic retinopathy. PROTEUS

Abstract

AbstractPurpose To compare efficacy and evaluate safety of intravitreal (ITV) injection of ranibizumab (0.5 mg) plus PRP versus PRP alone in the regression of retinal neovascularization (NV) in eyes with high‐risk proliferative diabetic retinopathy (HR‐PDR).Methods Primary Outcome: Regression of neovascularization (NV). Secondary Outcomes: 1) Best‐Corrected Visual Acuity (BCVA) loss – changes from baseline; 2) Time to NV regression; 3) Recurrence of neovascularization; 4) Macular retinal thickness by Optical Coherent Tomography (OCT) – changes from baseline; 5) Laser needed for Diabetic Macular Edema (DME); 6) Vitrectomy needed due to the occurrence of vitreous hemorrhage or retinal detachment; 7) Drug safety profile.Results This is a prospective, randomized, multicenter, open label, phase II / III study to assess efficacy and safety of ranibizumab plus PRP versus PRP alone in the treatment of subjects with HR‐PDR. Number Patients: 94 eyes from 94 diabetic patients: Randomized 1:1; Group 1: 47 eyes (PRP group); Group 2: 47 (ranibizumab + PRP).