RESUMO
To compare the results of intravitreal bevacizumb [IVB] injection alone or in combination with intravitreal triamcinolone acetonide [IVT] versus macular laser photocoagulation [MPC] as primary treatment of diabetic macular edema [DME]. In this randomized clinical trial, 150 eyes of 129 patients with clinical DME and no previous treatment were enrolled. The eyes were randomly assigned to one of the three study arms: the IVB group received 1.25 mg IVB [50 eyes]; the IVB/IVT group received 1.25mg of IVB and 2 mg of IVT [50 eyes]; and the MPC group underwent focal or modified grid laser [50 eyes]. Retreatment was performed at 12-week intervals whenever indicated. Visual acuity [VA] changes among the groups were statistically significant at 6 [P<0.001] and 24 [p=0.012] weeks. VA change was significant only in the IVB group at 12 weeks. VA changes +/- standard deviation at 36 weeks were -0.28 +/- 0.25, -0.04 +/- 0.33, and +0.01 +/- 0.27 LogMAR in the IVB, IVB/IVT, and MPC groups, respectively [P=0.053]. Significant reduction in central macular thickness [CMT] was observed in all groups only up to 6 weeks; however, CMT changes were not significantly different among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks [14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group]. In the IVB group, in which greater VA improvement was observed, only one injection was required in 72% of the cases. VA improvement more than 2 Snellen lines at 36 weeks occurred in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT and MPC groups, respectively. Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. After 6 weeks changes in CMT and VA were not compatible. No adjunctive effect of IVT was demonstrated