Topical nepafenec in eyes with noncentral diabetic macular edema

Scott M. Friedman, Talat H. Almukhtar*, Carl W. Baker, Adam R. Glassman, Michael J. Elman, Neil M. Bressler, Manvi P. Maker, Lee M. Jampol, Michele Melia

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

56 Scopus citations


Purpose: To evaluate the effect of a topical, nonsteroidal antiinflammatory drug, nepafenac 0.1%, in eyes with noncentral diabetic macular edema. Methods: Multicenter, double-masked randomized trial. Individuals with good visual acuity and noncentral-involved diabetic macular edema were randomly assigned to nepafenac 0.1% (N 61) or placebo (nepafenac vehicle, N 64) 3 times a day for 12 months. The primary outcome was mean change in optical coherence tomography retinal volume at 12 months. Results: Mean baseline retinal volume was 7.8 mm 3. At 12 months, in the nepafenac and placebo groups respectively, mean change in retinal volume was -0.03 mm 3 and -0.02 mm 3 (treatment group difference: -0.02, 95% confidence interval: -0.27 to 0.23, P 0.89). Central-involved diabetic macular edema was present in 7 eyes (11%) and 9 eyes (14%) at the 12-month visit (P 0.79), respectively. No differences in visual acuity outcomes were identified. One study participant developed a corneal melt after using nepafenac in the nonstudy eye, which had a history of severe dry eye. No additional safety concerns were evident. Conclusion: In eyes with noncentral diabetic macular edema and good visual acuity, topical nepafenac 0.1% 3 times daily for 1 year likely does not have a meaningful effect on optical coherence tomography-measured retinal thickness.

Original languageEnglish (US)
Pages (from-to)944-956
Number of pages13
Issue number5
StatePublished - May 8 2015


  • Diabetic Retinopathy Clinical Research Network
  • nepafenac
  • noncentral DME
  • topical NSAID

ASJC Scopus subject areas

  • Ophthalmology


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