Abstract
Purpose: :
To assess the safety and efficacy of pegaptanib maintenance in NV-AMD patients with clinical improvement of disease after recent treatment (induction).
Methods: :
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.
Results: :
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).
Conclusions: :
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.
Clinical Trial: :
www.clinicaltrials.gov NCT00354445
Keywords: age-related macular degeneration