Purpose: To examine the effect of 0.1% bromfenac (BF) ophthalmic solution and 0.1% betamethasone (BM) ophthalmic solution on diabetic macular edema (DME).
Methods: This was a prospective trial. Nineteen patients (mean age of 66.6 ± 10.1 years) with DME and mean retinal thickness within a diameter of 1 mm from the fovea (central subfield thickness: CST) of 250-500 µm were randomized and instilled with BF or BM. CST, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were measured at 4, 8, and 12 weeks after administration.
Results: CST at baseline (p = .128) and that at 4, 8, and 12 weeks of administration was not significantly different between the BF (10 patients) and BM groups (9 patients). In patients with glycated hemoglobin (HbA1c) <8.0%, CST, compared with baseline, was significantly decreased in the BF group (seven patients) at 8 (p = .025) and 12 weeks (p = .043) of administration. When compared with the baseline, no significant changes in BCVA were observed at any point in time in either group. Baseline IOP was comparable between the groups. In the BM group, the values of change in IOP from baseline significantly increased at 8 (p = .025) and 12 weeks (p = .044) of administration, with no significant changes in IOP over the 12 weeks of administration in the BF group.
Conclusions: BF did not affect IOP even after 12 weeks of administration, suggesting its effect in reducing CST in DME with good glycemic control.
Trial registration: University Hospital Medical Information Network (UMIN-CTR); UMIN000026201, February 18, 2017; Japan Registry of Clinical Trials; jRCTs031180308, March 15, 2019.
Keywords: Diabetic macular edema; betamethasone; bromfenac; central subfield thickness; intraocular pressure.