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) < 11% received either intravitreal bevacizumab injection (Group 1) or sham injection (Group 2) at 0 and 6 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 12 weeks.
Results: The study showed a mean CS improved in group 1 from 1.14 ± 0.36 logCS to 1.32 ± 0.24 logCS and also in group 2 from 1.11 ± 0.29 logCS to 1.18 ± 0.29 logCS at 12 weeks (P = 0.12). CS and CMT promptly decreased in group 1 compared to group 2 at 2 weeks (ΔCS = 0.15 ± 0.25 vs. 0.03 ± 0.15 logCS; P = 0.04; ΔCMT = 116 ± 115 vs. 17 ± 71 μm; P = 0.01). There was a mean reduction of approximately 0.5% in HbA1c levels in both groups at 12 weeks (P = 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 12 weeks. ClinicalTrials.gov Identifier: NCT02308644.
Keywords: Bevacizumab; Contrast sensitivity; Diabetic macular edema; Glycemic control.
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