期刊
RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES
卷 35, 期 5, 页码 944-956出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/IAE.0000000000000403
关键词
Diabetic Retinopathy Clinical Research Network; nepafenac; noncentral DME; topical NSAID
资金
- National Eye Institute
- National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services [EY14231, EY18817, EY023207]
- National Institutes of Health
- Bayer
- Genentech, Inc
- Novartis Pharma AG
- Regeneron
- Emmes Corporation through the Office of Research Administration of the Johns Hopkins University School of Medicine
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.
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