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Diabetic Retinopathy Clinical Research Network (DRCR.net)^*

Arch Ophthalmol. 2009;127(3):245-251.

Objective  To report 3-year outcomes of patients who participated in a randomized trial evaluating 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone compared with focal/grid photocoagulation for treatment of diabetic macular edema.

Methods  Eyes with diabetic macular edema and visual acuities of 20/40 to 20/320 were randomly assigned to focal/grid photocoagulation or 1 mg or 4 mg of triamcinolone. At the conclusion of the trial, 3-year follow-up data were available in 306 eyes.

Results  Between 2 years (time of the primary outcome) and 3 years, more eyes improved than worsened in all 3 treatment groups. Change in visual acuity letter score from baseline to 3 years was +5 in the laser group and 0 in each triamcinolone group. The cumulative probability of cataract surgery by 3 years was 31%, 46%, and 83% in the laser and 1-mg and 4-mg triamcinolone groups, respectively. Intraocular pressure increased by more than 10 mm Hg at any visit in 4%, 18%, and 33% of eyes, respectively.

Conclusions  Results in a subset of randomized subjects who completed the 3-year follow-up are consistent with previously published 2-year results and do not indicate a long-term benefit of intravitreal triamcinolone relative to focal/grid photocoagulation in patients with diabetic macular edema similar to those studied in this clinical trial. Most eyes receiving 4 mg of triamcinolone as given in this study are likely to require cataract surgery.

Trial Registration  clinicaltrials.gov Identifier: NCT00367133

*Writing Committee: The following members of the DRCR.net take authorship responsibility: lead authors: Roy W. Beck, MD, PhD, and Allison R. Edwards, MS. Additional writing committee members (in alphabetical order): Lloyd P. Aiello, MD; Neil M. Bressler, MD; Frederick Ferris, MD; Adam R. Glassman, MS; M. Elizabeth Hartnett, MD; Michael S. Ip, MD; Judy E. Kim, MD; and Craig Kollman, PhD.
Group Information: A list of the DRCR.net investigators and staff participating in this protocol was published in Ophthalmology. 2008;115(9):1447-1449.

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