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 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 overIVB monotherapy may exist; especially as regards anatomical features. In our therapeutic arsenal for DME, IVD can be added as an adjunct to Bevacizumab.