Authors
Ursula Schmidt-Erfurth, Gabriele E Lang, Frank G Holz, Reinier O Schlingemann, Paolo Lanzetta, Pascale Massin, Ortrud Gerstner, Abdelkader Si Bouazza, Haige Shen, Aaron Osborne, Paul Mitchell, RESTORE Extension Study Group
Publication date
2014/5/1
Journal
Ophthalmology
Volume
121
Issue
5
Pages
1045-1053
Publisher
Elsevier
Description
Objective
To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema (DME).
Design
Phase IIIb, multicenter, 12-month, randomized core study and 24-month open-label extension study.
Participants
Of the 303 patients who completed the randomized RESTORE 12-month core study, 240 entered the extension study.
Methods
In the extension study, patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity (BCVA) and disease progression criteria at the investigators' discretion. Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines. Based on the treatments received in the core study, the extension study groups were referred to as prior ranibizumab, prior ranibizumab + laser, and laser …
Scholar articles
U Schmidt-Erfurth, GE Lang, FG Holz… - Ophthalmology, 2014