RESUMO
AIMS: To analyze contrast sensitivity of intravitreal bevacizumab injections with optimizing glycemic control versus optimizing glycemic control (in combination with sham injections) in eyes with Diabetic Macular Edema (DME). DESIGN: Prospective, interventional, masked, randomized controlled trial. METHODS: Forty-one eyes of 34 patients with type 2 diabetes mellitus and DME with glycated hemoglobin (HbA1c)â¯<â¯11% received either intravitreal bevacizumab injection (Group 1) or sham injection (Group 2) at 0 and 6â¯weeks along with optimizing glycemic control. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS), optical coherence tomography (OCT)-measured by central macular thickness (CMT) were compared and correlated at baseline, 2, 6 and 12â¯weeks. RESULTS: The study showed a mean CS improved in group 1 from 1.14⯱â¯0.36 logCS to 1.32⯱â¯0.24 logCS and also in group 2 from 1.11⯱â¯0.29 logCS to 1.18⯱â¯0.29 logCS at 12â¯weeks (Pâ¯=â¯0.12). CS and CMT promptly decreased in group 1 compared to group 2 at 2â¯weeks (ΔCSâ¯=â¯0.15⯱â¯0.25 vs. 0.03⯱â¯0.15 logCS; Pâ¯=â¯0.04; ΔCMTâ¯=â¯116⯱â¯115 vs. 17⯱â¯71⯵m; Pâ¯=â¯0.01). There was a mean reduction of approximately 0.5% in HbA1c levels in both groups at 12â¯weeks (Pâ¯=â¯0.002). CONCLUSION: The use of bevacizumab in combination with optimizing glycemic control results in earlier improvement of contrast sensitivity in type 2 diabetes patients with DME. However, the optimizing glycemic control itself has shown also to be effective at 12â¯weeks. ClinicalTrials.gov Identifier: NCT02308644.