Abstract
Purpose: :
To test the efficacy of the topical non-steroidal anti-inflammatory drop, nepafenac, in the management of diabetic macular edema (DME).
Methods: :
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.
Results: :
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).
Conclusions: :
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.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00939276
Keywords: diabetic retinopathy • macula/fovea • inflammation