FRIDAY, Feb. 8 (HealthDay News) -- Details of a symposium sponsored by the National Eye Institute (NEI) and the U.S. Food and Drug Administration (FDA) to discuss clinical trial design and endpoints as well as postmarketing surveillance have been published in the February issue of Investigative Ophthalmology & Visual Science.
Karl G. Csaky, M.D., Ph.D., from Duke University Medical Center in Durham, N.C., and colleagues reported on the discussions that took place from Nov. 28-29, 2006, at the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium.
The purpose of the symposium was to develop standards for clinical trials in ophthalmology. The discussion consisted of five sections: visual acuity parameters as outcomes measures, endpoints in diabetic retinopathy, design and endpoints for neovascular age-related macular degeneration, design and endpoints for geographic atrophy, and postmarketing drug surveillance.
The authors note that technologies such as Fourier domain optical coherence tomography provide detailed scans of the retina, "opening a new frontier for patients with retinal disorders," and have the potential to serve as endpoints in clinical trials. However, the results do not always correlate with visual function. The FDA currently recommends that clinical trials use change in visual function as a primary endpoint as well as anatomic markers.
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