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

Abstract

The aim of this study is to evaluate the short-term effects of a single intravitreal injection of 1.25mg Bevacizumab combined with 300lg/0.1mL Diclofenac (IVB/D) versus 1.25mg 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.