Original articleA Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Focal/Grid Photocoagulation for Diabetic Macular Edema
Section snippets
Patients and Methods
This phase III randomized, multicenter clinical trial was conducted by the DRCR.net at 88 clinical sites in the United States. The study adhered to the tenets of the Declaration of Helsinki. The protocol and Health Insurance Portability and Accountability Act-compliant informed consent forms were approved by multiple institutional review boards. Each subject gave written informed consent to participate in the study. Study oversight was provided by an independent data and safety monitoring
Results
Between July 2004 and May 2006, 693 subjects (mean age±SD, 63±9 years; 49% women) were enrolled, 147 (21%) with 2 study eyes. The 840 study eyes with DME were assigned randomly to either focal/grid photocoagulation (n = 330), 1 mg triamcinolone (n = 256), or 4 mg triamcinolone (n = 254). At baseline, the mean±SD visual acuity letter score in study eyes was 59±11 (approximately 20/63) and the mean±SD OCT central subfield retinal thickness was 424±130 μm. The baseline characteristics of the 3
Discussion
This phase III randomized clinical trial compared 1-mg and 4-mg doses of preservative-free triamcinolone with focal/grid photocoagulation as treatments for eyes with DME and visual acuity ranging from 20/40 to 20/320. At 4 months, a greater positive treatment response on visual acuity was seen in the 4-mg triamcinolone group compared with the other 2 groups. However, by 1 year, there was little difference in visual acuity between the groups, and at the time of the 2-year primary outcome
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Manuscript no. 2008-530.
Available online: July 26, 2008.
A list of the members of the Diabetic Retinopathy Clinical Research Network participating in the trial appears in the online Appendix 1 available at http://aaojournal.org.
Writing Committee. Lead authors: Michael S. Ip, Allison R. Edwards, Roy W. Beck, Neil M. Bressler; additional writing committee members (in alphabetical order): Lloyd Paul Aiello, David J. Browning, Michael J. Elman, Scott M. Friedman, Frederick L. Ferris, Adam R. Glassman, Craig Kollman, Angela Price.
A complete list of all DRCR.net investigator financial disclosures can be found at www.drcr.net.
Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland (grant nos.: EY14231, EY14269, EY14229).
The funding organization participated in oversight of the conduct of the study and review of the manuscript but not directly in the design of the study, the conduct of the study, data collection, data management, data analysis, interpretation of the data, or preparation of the manuscript. Allergan, Inc., provided the triamcinolone and topical antibiotics after successfully competing for a request for proposals issued by DRCR.net for a company to provide a preservative-free triamcinolone for the study. As per the DRCR.net Industry Collaboration Guidelines (available at www.drcr.net), the DRCR.net had complete control over the design of the protocol, ownership of the data, and all editorial content of presentations and publications related to the protocol. Allergan, Inc., has provided unrestricted funds to DRCR.net for its discretionary use.
Correspondence: Michael S. Ip, MD, c/o Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647. E-mail: [email protected].