Original articleDexamethasone Intravitreal Implant in Combination with Laser Photocoagulation for the Treatment of Diffuse Diabetic Macular Edema
Section snippets
Methods
This randomized, double-masked, sham-controlled, phase 2 clinical study evaluated the safety and efficacy of the intravitreal DEX implant 0.7 mg in combination with laser photocoagulation therapy in diabetic patients with diffuse DME at 48 sites in the United States and Canada. The study duration was 1 year, with up to 3 months of additional follow-up. Institutional review board/ethics committee approval was obtained at each site, the study complied with the Health Insurance Portability and
Patient Population and Disposition
A total of 253 patients were enrolled in the study and were randomized to combination treatment with the DEX implant plus laser photocoagulation (DEX implant plus laser) or to treatment with sham plus laser photocoagulation (laser alone). Enrollment commenced in May 2007 and the study was completed in February 2010. Of the 253 patients in the ITT population, 200 (79.1%) had diffuse macular capillary bed leakage verified by a central reading center and were included in the mITT population for
Discussion
Patients with diffuse DME who were treated with DEX implant plus laser were not statistically different from the laser alone group at month 12 when looking at a 10-letter or more improvement from baseline (the primary outcome). The DEX implant plus laser group was significantly better than the laser alone group at week 1 and month 1, as well as at month 9 for this variable. Reductions in retinal thickness also favored DEX implant plus laser therapy over laser therapy alone at half of the time
Acknowledgments
Kate Ivins, PhD, a freelance medical writer funded by Allergan, Inc, prepared a manuscript draft under the direction of the authors.
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Manuscript no. 2012-467.
A full listing of the Ozurdex PLACID Study Group is available at http://aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
David G. Callanan: Consultant- Alcon, Allergan, Inc., Bausch and Lomb, Lux Biosciences, and Forsight
Sunil Gupta: Consultant - Allergan, Inc.
David S. Boyer: Consultant - Alcon, Allegro, Allergan, Inc., Genentech, Novartis, and Regeneron
Thomas A. Ciulla: Advisory Board - Allergan, Inc.
Michael A. Singer: Consultant - Allergan Inc., Genentech
Baruch D. Kuppermann: Consultant - Alimera, Allegro, Allergan, Inc., Fovea, Genentech, Glaukos, Neovista, Novagali, Novartis, Ophthotech, Regeneron, 2C Tech, and Thrombogenics
Ching-Chi Liu: Employee - Allergan, Inc.
Xiao-Yan Li: Employee - Allergan, Inc.
David A. Hollander: Employee - Allergan, Inc.
Rhett M. Schiffman: Employee - Allergan, Inc.
Scott M. Whitcup: Employee - Allergan, Inc.
Sponsored by Allergan, Inc., Irvine, California. The sponsor participated in design of the study, data management, data analysis, interpretation of the data, and the preparation, review, and approval of the manuscript.
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Group members listed online in Appendix 1 (available at http://aaojournal.org).