Evaluation of topical bromfenac as an adjunctive treatment with intravitreal ranibizumab in the management of diabetic macular edema

Background and purpose Intravitreal injection of anti- vascular endothelial growth factor medications has transformed the therapy of diabetic macular edema (DME). The purpose of this study was to evaluate the safety and efficacy of topical bromfenac as an adjunctive therapy to intravitreal ranibizumab injections in patients diagnosed with DME. Study design Prospective, randomized, controlled clinical trial. Patients The study included 40 eyes of patients with DME, divided into two groups: group I (20 eyes) received intravitreal ranibizumab injections and adjunctive topical bromfenac twice daily; group II (20 eyes) received only intravitreal ranibizumab injections. Methods All patients underwent assessments for best corrected visual acuity (BCVA), intraocular pressure, anterior segment, and fundus examination. Optical coherence tomography of the macula was repeated at 1, 3, and 6 months after the last injection. Results At 6 months, group I demonstrated significantly worse BCVA compared with group II ( P =0.021). In group II, the 6-month change in central macular thickness from baseline was significantly greater in patients aged less than or equal to 60 years compared with those greater than 60 years (median = –170.5 μm vs. −40 μm, respectively; P =0.001) and in females compared with males (median = –75 μm vs. −23.4 μm; P =0.012). No significant differences were observed concerning the duration of diabetes ( P =0.238), HbA1c levels ( P =0.315), or laterality ( P =0.792). Conclusion Topical bromfenac, when combined with intravitreal ranibizumab, showed some efficacy in the management of DME over a 6-month follow-up period, although the results were not statistically significant.