Intravitreal Bevacizumab (Avastin) Injection Alone or Combined with Triamcinolone versus Macular Photocoagulation as Primary Treatment for Diabetic Macular Edema; an Interim Analysis

To report the efficacy of a single intravitreal injection of bevacizumab (IVB) alone or in com-bination 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.