title: Topical nepafenec in eyes with noncentral diabetic macular edema.
abstract: OBJECTIVE
  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. At 12 months, in the nepafenac and placebo groups respectively, mean change in retinal volume was -0.03 mm and -0.02 mm (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: *Florida Retina Consultants, Lakeland, Florida; †Jaeb Center for Health Research, Tampa, Florida; ‡Paducah Retinal Center, Paducah, Kentucky; §Elman Retina Group, P.A., Philadelphia, Pennsylvania; ¶Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; **North Shore University Health System, Pritzker School of Medicine, University of Chicago, Glenview, Illinois; and ††Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Friedman
authors.forename: Talat H
authors.initials: TH
authors.lastname: Almukhtar
authors.forename: Carl W
authors.initials: CW
authors.lastname: Baker
authors.forename: Adam R
authors.initials: AR
authors.lastname: Glassman
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Elman
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.forename: Manvi P
authors.initials: MP
authors.lastname: Maker
authors.forename: Lee M
authors.initials: LM
authors.lastname: Jampol
authors.forename: Michele
authors.initials: M
authors.lastname: Melia
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D044482:Benzeneacetamides / Q000008:administration & dosage*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010648:Phenylacetates / Q000008:administration & dosage*; D012160:Retina / Q000473:pathology; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D009883:Ophthalmic Solutions; D010648:Phenylacetates; C414203:nepafenac