Intravitreal triamcinolone acetonide for diabetic macular edema: a prospective, randomized study.

ABSTRACT

PURPOSE: The aim of this study was to examine the visual outcome of patients receiving an intravitreal injection of triamcinolone acetonide (TA) as treatment of diffuse diabetic macular edema (DDME). METHODS: This prospective, placebo-controlled, randomized, clinical interventional study included 40 eyes (38 patients) with DDME, with 28 (70%) eyes randomized to treatment and 12 (30%) eyes randomized to receive a placebo injection. Thirty-six (36) (90%) eyes completed the 3-month study visit, and 32 (80%) eyes completed the 6-month study visit. The treatment group received an intravitreal injection of approximately 20 mg of TA. RESULTS: Visual acuity increased significantly (P < 0.001) in the study group by 3.4 +/- 2.5 Snellen lines. In the control group, visual acuity did not change significantly (P = 0.07) during follow-up. Difference in change of best visual acuity was significant (P < 0.001) between both groups. At 3 months after baseline, 11 (11/26; 42%) eyes and 10 (10/26; 39%) eyes, respectively, improved by at least 2 and 3 lines, respectively, in the study group, versus 2 (2/10; 20%) eyes and 1 (1/10; 10%) eye in the control group. At 6 months after baseline, 11 (11/23; 48%) eyes and 9 (9/23; 39%) eyes, respectively, improved by at least 2 and 3 lines, respectively, in the study group, versus 0 (0%) eyes and 0 (0%) eyes in the control group. The difference was significant for the 2-line improvement (P = 0.01) and 3-line improvement (P = 0.03). CONCLUSIONS: Using a dosage of approximately 20 mg of intravitreal TA, visual acuity temporarily increases for 6 months after injection.