Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation.
Author(s): Googe J, Brucker AJ, Bressler NM, Qin H, Aiello LP, Antoszyk A, Beck RW, Bressler SB, Ferris FL 3rd, Glassman AR, Marcus D, Stockdale CR
Affiliation(s): Southeastern Retina Associates, P.C., Knoxville, Tennessee, USA.
Publication date & source: 2011-06, Retina., 31(6):1009-27.
Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
PURPOSE: To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation. METHODS: Three hundred and forty-five eyes with a visual acuity of 20/320 or better, center-involved diabetic macular edema receiving focal/grid laser, and diabetic retinopathy receiving prompt panretinal photocoagulation were randomly assigned to sham (n = 123), 0.5-mg ranibizumab (n = 113) at baseline and 4 weeks, and 4-mg triamcinolone at baseline and sham at 4 weeks (n = 109). Treatment was at investigator discretion from 14 weeks to 56 weeks. RESULTS: Mean changes (+/-SD) in visual acuity letter score from baseline were significantly better in the ranibizumab (+1 +/- 11; P < 0.001) and triamcinolone (+2 +/- 11; P < 0.001) groups compared with those in the sham group (-4 +/- 14) at the 14-week visit, mirroring retinal thickening results. These differences were not maintained when study participants were followed for 56 weeks for safety outcomes. One eye (0.9%; 95% confidence interval, 0.02%-4.7%) developed endophthalmitis after receiving ranibizumab. Cerebrovascular/cardiovascular events occurred in 4%, 7%, and 3% of the sham, ranibizumab, and triamcinolone groups, respectively. CONCLUSION: The addition of 1 intravitreal triamcinolone injection or 2 intravitreal ranibizumab injections in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation is associated with better visual acuity and decreased macular edema by 14 weeks. Whether continued long-term intravitreal treatment is beneficial cannot be determined from this study.