ABSTRACT
To report the efficacy of a single intravitreal injection of bevacizumab [IVB] alone or in combination with intravitreal triamcinolone acetonide [IVT] versus macular laser photocoagulation [MPC] as primary treatment for diabetic macular edema [DME]. This randomized three-arm clinical trial included 103 eyes of 97 patients with clinically significant DME and no previous treatment. The eyes were randomly assigned to one of the three study arms: the IVB group received 1.25 mg IVB [37 eyes], the IVB/IVT group received 1.25 mg IVB together with 2 mg IVT [33 eyes], and the MPC group underwent focal or modified grid laser photocoagulation [33 eyes]. Primary outcome measure was change in best-corrected visual acuity [BCVA]. Changes in BCVA [logMAR] at 12 weeks were -0.22 +/- 0.23, -0.13 +/- 0.31 and +0.08 +/- 0.31 in the IVB, IVB/IVT and MPC groups, respectively. The marginal regression model based on generalized estimating equation analysis demonstrated that changes in visual acuity was statistically significant in the IVB group at both 6 [P<0.001] and 12 [P=0.024] weeks but only at 6 weeks in the IVB/IVT group. Significant decrease in central macular thickness [CMT] was observed in the IVB and IVB/IVT groups at 6 weeks. Up to 12 weeks, IVB treatment in eyes with DME yielded better visual outcome than laser photocoagulation, although it was not associated with a significant decrease in CMT. IVT seemed to have no further beneficial effect in combination with IVB