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T. R. Friberg, for the LEVEL Study Group; Pegaptanib as Maintenance Therapy in Neovascular Age-Related Macular Degeneration (NV-AMD): 9 and 12 Month Data From the LEVEL Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2886.
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To assess the safety and efficacy of pegaptanib as maintenance therapy in NV-AMD patients who experienced clinical improvement of disease after recent treatment (induction).
An ongoing, prospective, uncontrolled, 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 in size, center point thickness ≤275 µm or thinning of ≥100 µm on OCT following induction, and 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.
To date, 211 subjects have been followed for 36 weeks after a median of 15 weeks of induction therapy. Induction monotherapies were bevacizumab (39%), ranibizumab (32%), multiple agents (22%), and others (7%). Lesions were relatively dry postinduction: 69% had center point thickness ≤200 µm. During induction, mean VA improved from 50.3 to 65.8 letters and was relatively preserved during the maintenance phase (36-week mean: 62.5 letters). Gains from pre-induction to week 36 of ≥0 and ≥3 lines of VA occurred in 75% and 43% of subjects; 90% lost <3 lines. During pegaptanib maintenance, center point thickness (OCT) was stable. In all, 59% of subjects did not receive booster treatment; of those boosted, 60% had only 1 booster with a mean time to first booster of 125 days after the start of maintenance therapy. The week 36 adverse event profile was consistent with the VISION trial with no new ocular or systemic safety signals. In 107 subjects followed for 48 weeks, VA and anatomical findings reflected the 36-week results.
In this interim analysis, subjects showed relative visual and anatomical stability during pegaptanib maintenance. Pegaptanib maintenance reduces exposure and provides an alternative to nonselective anti-VEGF agents, which may be particularly important for NV-AMD patients at high risk for cardiovascular events.
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