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R. S. Katz, R. Vogel, K. McLeod, Fenretinide Study Group; A Phase II Multicenter, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects with Age-Related Macular Degeneration: Preliminary Demographic Data and Reasons for Screen Failure. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4918.
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Present baseline demographic characteristics, screen failures, and 1-year results from the population enrolled in a study comparing fenretinide 300mg, 100mg, or placebo taken QD in the treatment of geographic atrophy (GA).
Subjects diagnosed with GA from age-related macular degeneration in one or both eyes without active choroidal neovascularization were enrolled at 30 sites in the US. Inclusion criteria required each GA lesion to be within 250 µm of the fovea, with a total atrophic area of > 2.54 mm2 and < 20.32 mm2, determined by color photography graded by the Digital Angiography Reading Center (DARC, New York, NY). Subjects were excluded if the fundus autofluorescence pattern or study eye best corrected visual acuity did not meet established criteria. The primary outcome measure will be the change in total aggregated GA lesion area measured by fundus photography, a novel anatomical endpoint in this disease state.
Using these criteria led to a mean age of 78 years and mean lesion size of 9.44 mm2. Valuable information has been learned for enrollment for future studies. One-year results for this study are expected in the first half of 2009.
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