Journal article
Twenty-four-Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes - Protocol 3 with High Dose (READ-3) Study
Yasir J Sepah, Mohammad Ali Sadiq, David Boyer, David Callanan, Ron Gallemore, Michael Bennett, Dennis Marcus, Lawrence Halperin, Muhammad Hassan, Peter A Campochiaro, Quan Dong Nguyen, Diana V Do
OPHTHALMOLOGY | ELSEVIER SCIENCE INC | Published : 2016
Abstract
PURPOSE: To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME). DESIGN: Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial. PARTICIPANTS: A total of 152 patients (152 eyes) with DME. METHODS: Eligible eyes were randomized in a 1:1 ratio to 0.5 mg (n = 77) or 2.0 mg (n = 75) RBZ. Study eyes received 6 monthly mandatory injections followed by as-needed injections until month 24. MAIN OUTCOME MEASURES: The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean c..
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Funding Acknowledgements
[ "The author(s) have made the following disclosure(s): Y.J.S.: Consultant - Genentech, Astellas; Research support - Genentech.", "R.G.: Other - Genentech, pSivida, Allergan, Alcon, Allergan, Bausch & Lomb; Research Support - Genentech, pSivida, Allergan; Speaker - Alcon, Allergan, Bausch & Lomb.", "D.M.: Advisory board member and consultant - Genentech, Regeneron, Thrombogenics; Clinical research support - Genentech, Regeneron, Thrombogenics.", "P.A.C.: The George S. and Dolores Dore Eccles Professor of Ophthalmology and Neuroscience; Institutional consulting agreements - Genentech/Roche, Regeneron, Aerpio Therapeutics; Consultant - Alimera, Applied Genetic Technologies, AsclipiX, Rxi, Allegro, Intrexon, Regenxbio; Research support - AbbVie, Alimera, Allergan, Aerpio Therapeutics, Genentech/Roche, Genzyme, GlaxoSmithKline, Oxford Biomedica, Regeneron, Regenxbio, Rxi; Equity interest -Alimera, Allegro, Graybug; Royalties - Graybug. These activities are being managed by the Conflict of Interest Committee of the Johns Hopkins University School of Medicine.", "Q.D.N.: Recipient of the Physician Scientist Award from Research to Prevent Blindness (New York, NY); Consultant - Santen; Research support - Genentech, Santen, Ophthotech, Regeneron; Institutional consulting agreement - AbbVie; Honorarium - Bayer, XOMA; Chairs the Steering Committee for the RISE and RIDE Studies; Steering Committee - VISTA Study and other studies sponsored by Genentech and Regeneron.", "D.V.D.: Consultant - Genentech, Regeneron, Santen, Allergan; Research support - Genentech, Regeneron, Santen; Chairs the Steering Committee for the VISTA Study.", "READ-3 was an investigator-sponsored study with the investigative new drug for the study held by one of the investigators (Q.D.N.). The READ-3 Study was funded by JDRF International, with the study drug provided by Genentech, Inc." ]