COMPARATIVE EVALUATION OF INTRAVITREAL DICLOFENAC PLUS BEVACIZUMAB VERSUS BEVACIZUMAB ALONE IN THE TREATMENT OF NAÏVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL

OBJECTIVE: To evaluate the therapeutic effects of intra-vitreal injection Bevacizumab combined with Diclofenac-Na versus intra-vitreal Bevacizumab alone in the treatment of naïve diabetic macular edema. METHODS: In this prospective, randomized interventional clinical trial, 40 eyes of 40 participants were enrolled for trial conducted at an Ophthalmology department of Qazi Hussain Medical Complex, Nowshera. Twenty eyes each included in the intra-vitreal Bevacizumab and bevacizumab plus diclofenac group via random sampling technique. The main outcome variable was a change in best-corrected visual acuity (BC-VA) in log MAR at 4th, 12th and 24th week. The secondary outcomes included mean change in central subfield thickness (CSFT) of macula and possible injection-related side effects. RESULTS: Marked improvement in BC-VA was observed in both therapeutic groups (mean change in Log MAR: 0.324±0.411 and 0.562±0.388 for bevacizumab alone and combination group, respectively). The difference in BC-VA change was in favor of combination group; however, the level didn’t achieve statistical significance (p = 0.08). Significant decrease in CSFT was noted in both groups (mean reductions: 178.02 ± 166.42, 214.55 ± 132.65) for bevacizumab and combination, respectively). Comparison of CSFT changes between groups revealed that combination decreased CSFT more than bevacizumab, but the difference was statistically insignificant (p = 0.07). Neither injection related side effects nor any marked change in intraocular pressure was observed in either groups. CONCLUSION: In diabetic macular edema, superiority of combination therapy over Bevacizumab alone was evident, esp. with regard to structural improvement in macula.