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Josh O. Wallsh, Mehran Taban, Ben Sharareh, Elijah Moon, Ron P. Gallemore; Exploratory Study of Nepafenac as Adjunctive Therapy for Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2011;52(14):560.
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To test the efficacy of the topical non-steroidal anti-inflammatory drop, nepafenac, in the management of diabetic macular edema (DME).
A randomized, double-masked, exploratory study of topical nepafenac 0.1% versus placebo as adjuntive therapy for DME undergoing standard of care treatment with focal laser using endpoints of central macular thickness, visual acuity, and number of focal laser treatments. High-resolution OCT was used to measure macular thickness (Cirrus, Zeiss Ophthalmics). A vehicle drop was used as the control. In addition, Argon focal laser was applied when indicated at baseline and thereafter as indicated using ETDRS criteria.
At 8 months, visual acuity decreased an average of 4.67±13.17 ETDRS letters and central macular thickness increased an average of 27.33±66.81 microns in the control group (n = 6) versus an increase of 1.14±6.85 ETDRS letters and a decrease of 17.58±33.46 microns in the treatment group (n = 7). The mean number of focal laser treatments was 53.44±34.67 applications for the control group (n = 9) versus 44.43±30.77 applications for the treatment group (n = 10).
Nepafenac reduced macular thickness, improved visual acuity, and reduced the number of laser applications compared to the control group for patients with DME. A larger study with increased power is warranted.
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