PURPOSE: To evaluate the efficacy and safety of topical bromfenac in patients with newly diagnosed diabetic macular edema (DME). METHODS: In this pilot study including 17 patients with monocular, newly diagnosed DME, diagnosis of DME was established by the detection of retinal thickening at or within 500 μm of the center of the macula on ophthalmoscopic examination, according to the Early Treatment Diabetic Retinopathy Study classification. Central macular thickness (CMT) was determined by optical coherence tomography. Bromfenac sodium hydrate 0.9 mg/mL eyedrops were administered in the affected eye twice daily for 30 days. Primary endpoints were changes in best-corrected visual acuity (BCVA) and CMT at the end of therapy. RESULTS: Topical bromfenac significantly reduced mean CMT, from 465.41 ± 118.47 μm at baseline to 388.88 ± 152.63 μm posttreatment (p = 0.02). There was no significant change in BCVA and differences in mean macular volume fell just short of statistical significance (p = 0.06). Treatment was well-tolerated, and there were no topical or systemic side effects. CONCLUSIONS: Topical bromfenac twice daily may play a role in the reduction of DME. These preliminary results warrant further larger multicenter studies to confirm our findings and establish whether topical bromfenac may be of long-term benefit in the treatment of DME.
PURPOSE: To evaluate the efficacy and safety of topical bromfenac in patients with newly diagnosed diabetic macular edema (DME). METHODS: In this pilot study including 17 patients with monocular, newly diagnosed DME, diagnosis of DME was established by the detection of retinal thickening at or within 500 μm of the center of the macula on ophthalmoscopic examination, according to the Early Treatment Diabetic Retinopathy Study classification. Central macular thickness (CMT) was determined by optical coherence tomography. Bromfenac sodium hydrate 0.9 mg/mL eyedrops were administered in the affected eye twice daily for 30 days. Primary endpoints were changes in best-corrected visual acuity (BCVA) and CMT at the end of therapy. RESULTS: Topical bromfenac significantly reduced mean CMT, from 465.41 ± 118.47 μm at baseline to 388.88 ± 152.63 μm posttreatment (p = 0.02). There was no significant change in BCVA and differences in mean macular volume fell just short of statistical significance (p = 0.06). Treatment was well-tolerated, and there were no topical or systemic side effects. CONCLUSIONS: Topical bromfenac twice daily may play a role in the reduction of DME. These preliminary results warrant further larger multicenter studies to confirm our findings and establish whether topical bromfenac may be of long-term benefit in the treatment of DME.
Authors: Fernando J Cabrera; Daniel C Wang; Kartik Reddy; Ghanashyam Acharya; Crystal S Shin Journal: Drug Discov Today Date: 2019-06-05 Impact factor: 7.851
Authors: Nicolás Cabrera; Sebastián A Cuesta; José R Mora; Luis Calle; Edgar A Márquez; Roland Kaunas; José Luis Paz Journal: Pharmaceutics Date: 2022-01-19 Impact factor: 6.321