Abstract
Purpose: :
To report 3-year follow up of a randomized trial evaluating 1 mg and 4 mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).
Methods: :
Eyes with DME and visual acuity 20/40 to 20/320 were randomly assigned to focal/grid photocoagulation, 1 mg triamcinolone, or 4 mg triamcinolone. At the conclusion of the trial, 3-year follow up was available for 306 eyes.
Results: :
Between two and three years of follow up, more eyes in all three treatment groups improved than worsened with respect to visual acuity and OCT central subfield thickness. Mean change in the visual acuity letter score from baseline to 3 years was +5 in the laser group and 0 in each triamcinolone group. Mean change in the central subfield from baseline to 3 years was -175 microns in the laser group, -124 microns in the 1 mg triamcinolone group and -126 microns in the 4 mg triamcinolone group. The cumulative probability of cataract surgery by three years was 31%, 46%, and 83% in the laser, 1 mg triamcinolone, and 4 mg triamcinolone groups, respectively. Intraocular pressure increased ≥10 mm Hg at any visit in 4%, 18%, and 33%, respectively.
Clinical Trial: :
www.clinicaltrials.gov NCT00367133
Keywords: diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • corticosteroids