[Intravitreal bevacizumab [avastin] injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment for diabetic macular edema; an interim analysis]

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