Journal
GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY
Volume 257, Issue 11, Pages 2375-2380Publisher
SPRINGER
DOI: 10.1007/s00417-019-04383-2
Keywords
Diabetic macular edema; Nerve fiber layer thickness; Bevacizumab; Erythropoietine; Optical coherence tomography
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Purpose To evaluate the effect of three intravitreal bevacizumab (IVB) injections alone or in combination with intravitreal erythropoietin (EPO) in the treatment of refractory diabetic macular edema (DME). Methods In a randomized double-blind clinical trial, 48 eyes of 34 diabetic patients with refractory DME were enrolled. Eyes were randomly assigned to receive either 3 monthly injections of 0.05 cc (1.25 mg) IVB plus 0.05 cc (1000 unit) EPO or 0.05 cc (1.25 mg) IVB alone. Main outcome was best-corrected visual acuity (BCVA) changes and secondary outcome was central macular thickness (CMT). The patients were followed for 6 months. Results Mean BCVA changes up to 4 and 6 months were insignificant in both groups. It changed from 0.72 +/- 0.56 logMAR at baseline to 0.74 +/- 0.5 (P = 0.85) and 0.71 +/- 0.44 (P = 0.40) in the combination group and from 0.48 +/- 0.39 logMAR to 0.47 +/- 0.35 (P = 0.48) and 0.52 +/- 0.33 (P = 0.69) in the IVB alone group, at 4 and 6 months, respectively. The difference of mean BCVA changes between the groups was insignificant at both 4 and 6 months (P = 0.07 and P = 0.36, respectively). Within the group changes of mean CMT were significant only in the combination group at 4 and 6 months, from 518 +/- 134 mu at baseline to 472 +/- 151 to 475 +/- 167 mu, respectively (P = 0.01 and P = 0.05). Corresponding changes were not significant in the IVB alone group. However, the difference between the groups was not significant at all visits (P = 0.51 and P = 0.71, respectively). Conclusions This clinical trial demonstrated that intravitreal erythropoietin had no additional effect to IVB in the treatment of refractory DME in the short term.
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