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Joseph M. Googe, Jr., Diabetic Retinopathy Clinical Research Network; Randomized Trial Evaluating Short-term Effects Of Intravitreal Ranibizumab Or Triamcinolone Acetonide On Macular Edema Following Focal/grid Laser For Diabetic Macular Edema In Eyes Also Receiving Panretinal Photocoagulation. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3970.
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To evaluate short term effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema (DME) and panretinal photocoagulation (PRP).
Three hundred forty-five eyes with a visual acuity (Snellen equivalent) of 20/320 or better, center-involved DME receiving focal/grid laser, and diabetic retinopathy receiving prompt PRP were randomly assigned to sham (n=123), 0.5-mg ranibizumab (n=113) at baseline and 4 weeks, or 4-mg triamcinolone at baseline and sham at 4 weeks (n=109). Follow-up visits were conducted at 1, 4, 14 (primary outcome), 34, and 56 weeks after randomization. Treatment was at investigator discretion after the 14-week visit.
Mean changes (±standard deviation) 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 the sham group (-4±14) at the 14-week visit. Reduction in mean central subfield thickness mirrored the visual acuity outcomes. These results were not maintained by 56 weeks. One eye (0.9%, 95% CI: 0.02% to 4.7%) developed endophthalmitis after receiving ranibizumab. Cerebrovascular/cardiovascular events through the 56-week visit occurred in 4%, 7%, and 3% of the sham, ranibizumab, and triamcinolone groups, respectively.
The addition of 1 intravitreal triamcinolone or 2 ranibizumab injections in eyes receiving focal/grid laser for DME and PRP is associated with better visual acuity and decreased macular edema by 14 weeks, but these effects are not maintained by 56 weeks with discontinuation of these protocol-defined intravitreal treatments after 4 weeks.
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