Original articleA Phase II Randomized Clinical Trial of Intravitreal Bevacizumab for Diabetic Macular Edema
Section snippets
Participants and Methods
This phase II randomized multicenter clinical trial was conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) at 36 clinical sites in the United States. The protocol and Health Insurance Portability and Accountability Act–compliant informed consent forms were approved by multiple institutional review boards. An investigational new drug application number (100 050) was obtained from the FDA for the protocol. Study oversight was provided by an independent data and safety
Results
Between June 5, 2006 and August 4, 2006, 121 subjects were randomized to the 5 treatment groups (one eye per subject) at 36 clinical sites. Of these 121 subjects, 109 met criteria for inclusion in the analyses (19–24 per group; exclusions detailed in Fig 1 [available at http://aaojournal.org]). Median age was 65 years, and 39% were women. The racial/ethnicity distribution was 76% white, 16% black, 6% Hispanic, 1% Asian, and 1% other. Type 2 diabetes was present in 93% and type 1 diabetes in 7%.
Discussion
To assist in the development of a phase III randomized trial protocol, this study was designed to address 6 questions related to the short-term effect of intravitreal bevacizumab for DME plus provide preliminary ocular and systemic safety data.
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Manuscript no. 2007-411.
Supported through a cooperative agreement from the National Eye Institute, Bethesda, Maryland, and National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland (nos. EY14231, EY14269, EY14229), and by a grant from the Juvenile Diabetes Research Foundation International, New York, New York.
For a listing of financial disclosures for all Network investigators as of date of submission, see the DRCR.net Web site (http://www.drcr.net).
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See “Appendix 2” (available at http://aaojournal.org) for a complete list of the Network’s members participating in the trial.