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Intravitreal Diclofenac plus Bevacizumab versus Bevacizumab alone in treatment-naive diabetic macular edema: a randomized double-blind clinical trial

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Abstract

The aim of this study is to evaluate the short-term effects of a single intravitreal injection of 1.25 mg Bevacizumab combined with 300 lg/0.1 mL Diclofenac (IVB/D) versus 1.25 mg intravitreal Bevacizumab (IVB) alone in the treatment of naive diabetic macular edema (DME). In this prospective, randomized clinical trial, 80 eyes were included in the final analysis; 42 and 38 of which in the IVB and IVB/D groups, respectively. The primary outcome measure was a change in best-corrected visual acuity (BCVA) in logMAR at week 4. The secondary outcomes included changes in central macular thickness (CMT), macular volume, and potential injection-related complications. Significant improvement of BCVA was demonstrated in both study arms (mean reductions in LogMAR: −0.088 ± 0.278, −0.228 ± 0.330 for IVB and IVB/D, respectively). The difference in BCVA changes was in favor of IVB/D; however, not to a statistically significant level (P = 0.160). Significant reduction of CMT was documented in both study arms (mean reductions: 82.43 ± 160.09 and 153.26 ± 163.85 for IVB and IVB + IVD, respectively). Comparison of CMT changes between groups showed that IVB/D reduced CMT more than that of IVB (P = 0.04). Effects on macular volume corresponded to those of CMT. No injection-related complications or significant alterations in intraocular pressure were observed in any of the study arms. In treatment-naive DME, superiority of IVB/D combination therapy over IVB monotherapy may exist; especially as regards anatomical features. In our therapeutic arsenal for DME, IVD can be added as an adjunct to Bevacizumab.

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Acknowledgments

The authors are very grateful to the patients and their relatives for their collaboration with this research. This survey was conducted with the cooperation of Isfahan University of Medical Sciences (IUMS) and Isfahan Eye Research Center (IERC). This work was supported by Isfahan University of Medical Sciences (Grant Number 391041).

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Correspondence to Seyed Ali Sonbolestan.

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Ghanbari, H., Kianersi, F., Sonbolestan, S.A. et al. Intravitreal Diclofenac plus Bevacizumab versus Bevacizumab alone in treatment-naive diabetic macular edema: a randomized double-blind clinical trial. Int Ophthalmol 37, 867–874 (2017). https://doi.org/10.1007/s10792-016-0335-z

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  • DOI: https://doi.org/10.1007/s10792-016-0335-z

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