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M. Goldbaum, for the LEVEL Study Group; Interim 1-year Safety Results of the LEVEL Study: Maintenance Therapy with Pegaptanib Sodium (Macugen®) in Patients With Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1912.
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To present the 1-year safety profile of a maintenance regimen of pegaptanib sodium in patients with neovascular age-related macular degeneration (NV-AMD) who had experienced visual improvement following recent treatment.
Prospective, phase 4, open-label, multicenter study enrolled subjects ≥50 years of age with subfoveal NV-AMD who experienced clinical or anatomical improvement in response to prior induction therapy consisting of ≥1 and ≤3 previous NV-AMD treatments administered within 30 to 120 days prior to study entry. Lesions of all angiographic subtypes, ≤12 disc areas were eligible; additional inclusion criteria included visual acuity (VA) of 20/20 to 20/400, and optical coherence tomography (OCT) center point thickness ≤275 microns or having demonstrated retinal thinning of ≥100 microns in response to induction therapy. Maintenance therapy consisted of 0.3 mg intravitreal pegaptanib, administered every 6 weeks for 48 weeks with follow-up through week 54. At investigator discretion, worsening of NV-AMD at any time could be treated by any booster treatment. Safety endpoints included all ocular and systemic adverse events and abnormal laboratory findings.
To date, 568 subjects have received one dose of study treatment; 88% have completed 1 year of pegaptanib therapy after a median of 15 weeks of induction therapy. Induction monotherapies were ranibizumab (42%), bevacizumab (36%), multiple agents (19%), and others (2%). The most common ocular adverse events were transient, mild to moderate in intensity, and attributed to the injection preparation and procedure. Interim assessment at week 36 revealed no evidence on an increased risk of systemic complications. Complete 1-year data will be presented.
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