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P. A. Weber, for the LEVEL Study Group; Efficacy and Safety of Maintenance Therapy With Pegaptanib Sodium in Neovascular AMD (NV-AMD) - 1-Year Results of the LEVEL Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5227.
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To assess the safety and efficacy of pegaptanib maintenance in NV-AMD patients with clinical improvement of disease after recent treatment (induction).
Prospective, open-label, multicenter U.S. study enrolled subjects ≥50 years of age with subfoveal NV-AMD and ≥1 and ≤3 NV-AMD treatments 30-120 days prior to study entry that resulted in investigator-determined clinical/anatomical NV-AMD improvement. Eligible subjects had lesions of any subtype ≤12 disc areas, center point thickness (CPT) ≤275 µm or thinning of ≥100 µm on OCT following induction, visual acuity (VA) 20/20 to 20/400. Intravitreal pegaptanib 0.3 mg was administered every 6 weeks for 48 weeks, with booster treatments using other agents allowed at the investigator’s discretion for deteriorating NV-AMD.
A total of 568 subjects were enrolled; 88% have completed 1 year of pegaptanib therapy after a median of 15 weeks of induction. Induction monotherapies were ranibizumab (42%), bevacizumab (36%), multiple agents (19%), and others (2%). Lesions were relatively dry postinduction: 64% had CPT ≤200 µm. During induction, mean VA improved from 49.6 to 65.5 letters and was relatively preserved during the maintenance phase (54-week mean: 61.8 letters). Gains from preinduction to week 54 of ≥0 and ≥3 lines of VA occurred in 79% and 41% of subjects; 92% lost <3 lines. During pegaptanib maintenance, CPT (OCT) was stable. VA response during pegaptanib maintenance was similar with subjects stratified by induction agent; best 50% vs worst 50% preinduction VA, postinduction VA, or postinduction CPT; or by ≥1 letter vs ≥10 letter improvement postinduction. Through week 54, 50% of subjects did not receive booster treatment; of those boosted, 46% had only 1 booster (mean time to first booster=165 days after maintenance therapy start).
After 54 weeks, subjects showed relative visual and anatomical stability during pegaptanib maintenance. Maintenance with pegaptanib reduces exposure and provides an alternative to nonselective anti-VEGF agents.
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