Topical nepafenec in eyes with noncentral diabetic macular edema.

Abstract

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. 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.

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.

• Authors: 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, Diabetic Retinopathy Clinical Research Network
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 35 Issue 5 Pg. 944-56 (May 2015) ISSN: 1539-2864 [Electronic] United States
• PMID: 25602634 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Benzeneacetamides
• Ophthalmic Solutions
• Phenylacetates
• nepafenac

Topics

• Administration, Topical
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Benzeneacetamides (administration & dosage)
• Diabetes Mellitus, Type 1 (complications)
• Diabetes Mellitus, Type 2 (complications)
• Diabetic Retinopathy (drug therapy, physiopathology)
• Double-Blind Method
• Female
• Humans
• Macular Edema (drug therapy, physiopathology)
• Male
• Middle Aged
• Ophthalmic Solutions
• Phenylacetates (administration & dosage)
• Retina (pathology)
• Tomography, Optical Coherence
• Visual Acuity (physiology)