Original articleRandomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion
Section snippets
Study Design
Two randomized, prospective, multicenter, masked, sham-controlled, parallel-group clinical trials were conducted in compliance with regulatory obligations, the Declaration of Helsinki, and the institutional review board and informed consent regulations at each investigational site. These trials are registered at clinicaltrials.gov as NCT00168324 and NCT00168298. Two separate phase III clinical trials (each of which included patients with BRVO and patients with CRVO) were conducted for
Results
Patients were recruited into this study between November 2004 and March 2008. A total of 1267 patients (DEX implant 0.7 mg: n = 427; DEX implant 0.35 mg: n = 414; sham: n = 426) were enrolled, and the majority of patients (1196/1267; 94%) completed day 180 (Fig 1). There was no statistically significant between-group difference with regard to the number of patients who completed or withdrew from the study before day 180. Fifteen of 1267 patients (1.2%) withdrew from the study because of ocular
Discussion
A single treatment with DEX implant 0.7 or 0.35 mg produced significantly greater improvements in visual acuity than did a sham procedure in eyes with vision loss due to ME associated with BRVO or CRVO. This was evident in the results for several efficacy measures, including the time to achieve a 15-letter improvement from baseline BCVA (primary outcome measure for the 2 pooled studies), the proportion of eyes achieving at least a 15-letter improvement, the proportion of eyes with BCVA
Acknowledgments
The writing assistance and manuscript preparation services of Amy Lindsay, PhD (Lindsay Biomedical Communications, Inc.), were retained by Allergan, Inc., for the writing committee. Dr. Lindsay, who did not meet authorship criteria, attended all meetings and conference calls of the writing committee; collated committee drafts, comments, and references; compiled an outline for discussion and review; drafted a first manuscript iteration on the basis of committee discussion and reworking of the
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Manuscript no. 2009-1609.
*GENEVA: Global Evaluation of implaNtable dExamethasone in retinal Vein occlusion with macular edemA. A list of the members of the GENEVA study group is available at http://aaojournal.org.
This article contains online-only material. The following should appear online only: Figure 3 and The GENEVA Study Group.
Financial Disclosure(s): The author(s) have made the following disclosure(s): Dr. Haller is a consultant with Genentech and Allergan and an equity owner with Macusight and OptiMedica. Dr. Bandello is a consultant and lecturer with Allergan and Novartis. Dr. Belfort is a consultant and lecturer with Allergan and Alcon. Dr. Blumenkranz is a consultant with Allergan, Macusight, and Genentech, an equity owner with Macusight and Optimedica, a lecturer with Allergan, and a patent holder with Optimedica. Dr. Gillies is a consultant with Allergan, Novartis, and Pfizer. Dr. Heier is a consultant for and received financial support from Alimera, Allergan, Genetech, and Regeneron, and is a lecturer for Regeneron. Dr. Lowenstein is a consultant for Allergan and Notal Vision and a lecturer for Novartis and Alcon. Dr. Yoon is a consultant for Allergan and a lecturer for Alcon. Drs. Jacques, Jiao, Li, and Whitcup are employees of Allergan, Inc.
Sponsored by Allergan, Inc., which participated in the design of the study, data analysis, and interpretation, and supervised the preparation of the manuscript and approved the final version.
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Group members listed online in Appendix 1 (available at http://aaojournal.org).