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R. Vogel, J. Slakter, K. McLeod; A Phase II, 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: Baseline Lesion Size, Characteristics, and Preliminary Progression Data. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4919.
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Present baseline lesion sizes, retinol-binding protein (RBP) levels, and preliminary lesion growth rates from a pivotal study comparing fenretinide and placebo in the treatment of geographic atrophy (GA) in subjects with age-related macular degeneration (AMD). Fenretinide binds with RBP and reduces retinol uptake by the pigment epithelium; in preclinical studies this has reduced lipofuscin and A2E production, which are increased in GA. This is a 2-year study with a 1-year efficacy analysis.
Two hundred forty-six subjects enrolled at 30 sites in the US were randomized to fenretinide 100 mg or 300 mg or placebo softgel capsules QD. Included subjects had a total atrophic area of 2.54 mm² to 20.32 mm² (> 1 to < 8 disc areas [DA]) in one or both eyes as determined by the Digital Angiography Reading Center (DARC, New York, NY), using fundus photography and fluorescein angiography. The baseline measurements included: fundus autofluorescence, visual acuity (VA), reading rate, contrast sensitivity, microperimetry, night vision, serum RBP levels, and full labs. Study visits were months1, 3, 6, and 12. Primary efficacy outcome is a novel anatomical endpoint---the growth rate of the aggregate GA lesion area. Secondary endpoints include the relationship between serum RBP and change in the GA area. It is expected that approximately 76% of subjects would otherwise progress 0.5 DA or more in a period of 1 year, with an average change of >1 DA This study is powered to detect a 50% decrease in the study eye aggregate GA lesion growth rate.
At baseline the mean age (range) was 78 (53-90) yrs; mean GA lesion area in the study eye was 9.72 (+5.19) mm2; mean serum RBP level 5.94 (+1.58)mg/dL; mean VA 67.69 (+10.73) letters. There was no tendency for lesion area to be correlated to serum RBP before treatment commenced. Age and lesion size were also not correlated at baseline, and no correlation was found between lesion area and VA. One-year progression rates for geographic atrophy in each treatment group will be presented.
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