PT  - JOURNAL ARTICLE
AU  - Thomas R Friberg
AU  - Michael Tolentino
AU  - for the LEVEL Study Group
TI  - Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study
AID  - 10.1136/bjo.2009.174946
DP  - 2010 Dec 01
TA  - British Journal of Ophthalmology
PG  - 1611--1617
VI  - 94
IP  - 12
4099  - http://bjo.bmj.com/content/94/12/1611.short
4100  - http://bjo.bmj.com/content/94/12/1611.full
SO  - Br J Ophthalmol2010 Dec 01; 94
AB  - Aim To assess the efficacy of pegaptanib as maintenance therapy in neovascular age-related macular degeneration (NV-AMD) patients after induction therapy.Methods A phase IV, prospective, open-label, uncontrolled exploratory study including subjects with subfoveal NV-AMD who had had one to three induction treatments 30–120 days before entry and showed investigator-determined clinical/anatomical NV-AMD improvement. Lesions in the study eye were: any subtype, 12 or fewer disc areas; postinduction centre point thickness (CPT) 275 μm or less or thinning of 100 μm or more (optical coherence tomography); visual acuity (VA) 20/20–20/400. Intravitreal pegaptanib 0.3 mg was administered as maintenance every 6 weeks for 48 weeks with follow-up to week 54. Booster treatment additional unscheduled treatment for wet age-related macular degeneration, was allowed in the study eye at the investigators' discretion for clinical deterioration.Results Of 568 enrolled subjects, 86% completed 1 year of pegaptanib. Mean VA improvement during induction (49.6 to 65.5 letters) was well preserved (54-week mean 61.8 letters). Mean CPT was relatively stable during maintenance (20 μm increase during the study). Fifty per cent did not receive unscheduled booster treatment to week 54; 46% did have one such booster (mean 147 days after maintenance initiation).Conclusions An induction-maintenance strategy, using non-selective then selective vascular endothelial growth factor (VEGF) inhibitors, could be considered for NV-AMD. This approach may have particular relevance for patients with systemic comorbidities who require long-term anti-VEGF therapy for NV-AMD.