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J.A. Wells, III, Pegaptanib in Central Retinal Vein Occlusion StudyGroup; Pegabtanib Sodium for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4279.
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To assess the efficacy and safety of treatment with pegaptanib sodium for macular edema secondary to central retinal vein occlusion (CRVO).
Randomized, multicenter, double–masked, sham controlled trial including patients with recent vision loss due to macular edema secondary to central retinal vein occlusion. Symptoms onset within 6 months from baseline. Subjects were randomized to receive either intravitreous pegaptanib sodium (0.3 mg or 1 mg) or sham injections every 6 weeks for 24 weeks. Photocoagulation was permitted for neovascularization according to the Central Vein Occlusion Study (CVOS) protocol. The primary endpoint was mean change in visual acuity from baseline to week 30 using ETDRS vision charts. Secondary endpoints included optical coherence tomography, fluorescein angiography, and color photographic assessments as well as population pharmacokinetics as determined at week 52.
A total of 98 subjects were enrolled; 48% were women and 52% men. The average age at baseline was 61.8 years. The study eye was the right eye in 47% of the cases. The mean visual acuity in the study eye at baseline was 50.4 letters (∼20/100 Snellen equivalent). Study design and preliminary results will be presented, as will representative case histories and ancillary testing results.
VEGF has at least two distinct biologic properties – inhibiting angiogenesis, and increasing vascular permeability. Selective VEGF blockade and ensuing restoration of the blood–retina barrier has previously been validated in the model of diabetic macular edema. This clinical trial examines its relevance to the macular edema seen following retinal venous occlusion.
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