Are Intravitreal Injections of Bevacizumab with Methotrexate Effective for Treatment of Diabetic Macular Edema A Randomized, Sham-Controlled Trial

Purpose: This study aimed to evaluate the efficacy and safety of three courses of intravitreal bevacizumab (IVB)combined with intravitreal methotrexate (IVM) in the treatment of diabetic macular edema (DME). Methods: In this prospective, randomized, sham-controlled trial, 36 treatment-naive eyes of 18 diabetic patients with DME were included. Both eyes of each patient were randomly allocated to receive three courses of either IVB (125 mg) with IVM (400 μg; 0.16 cc) (with 15 days interval) or IVB alone as a sham group. The outcome measure was change in best-corrected visual acuity (BCVA), central macular thickness (CMT), and central macular volume (CMV). The treatment was repeated at 1, 2, and 3 months after the first IV injection. Results: A significant improvement in BCVA at 3 months after the treatment was observed in both the groups (P< 0.001). A significant decrease in CMV was observed in the IVB/M group (P = 0.02) and IVB group (P = 0.04) during the study compared with the baseline. The mean ± SD of BCVA (LogMAR) after month 3 was 0.75 ± 0.54 and 0.70 ± 0.51 in the IVB/M and IVB groups, respectively (P = 0.17). There was no significant difference in the IOP during the study within (IVB/M group: P = 0.77 vs. IVB group: P = 0.06) and between the groups (P = 0.17) Conclusion: This study demonstrated no significant therapeutic effects of IVB combined with IVM compared with IVB alone in treatment-naive DME during a 3-month course.