Two-Year Safety and Efficacy of Ranibizumab 0.5 mg in Diabetic Macular Edema: Interim Analysis of the RESTORE Extension Study – Corrected Proof
Objective: To evaluate the 2-year safety and efficacy of ranibizumab 0.5 mg in diabetic macular edema (DME).Design: Twenty-four-month, open-label, multicenter, Phase IIIb extension study.Participants: Two hundred forty of 303 patients with visual impairment due to DME who completed the RESTORE core study and entered the extension.Methods: All patients were eligible to receive ranibizumab 0.5 mg pro re nata (PRN) from month 12 (end of core study) to month 36 based on best-corrected visual acuity (BCVA) stability and disease progression retreatment criteria. Patients were also eligible to receive laser PRN according to Early Treatment Diabetic Retinopathy Study guidelines. A preplanned interim (Read more...)