Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study
OPEN ACCESS- Thomas R Friberg1,
- Michael Tolentino2,
- for the LEVEL Study Group
- 1Ophthalmology, University of Pittsburgh Medical Center Eye Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
- 2Center for Retina and Macular Disease, Winter Haven, Florida, USA
- Correspondence to Dr Thomas R Friberg, Retina Service, Eye and Ear Institute, Room 825, 203 Lothrop Street, Pittsburgh, PA 15213, USA; friberg{at}pitt.edu
- Accepted 2 February 2010
- Published Online First 14 May 2010
Abstract
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.
Footnotes
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Funding This study was sponsored by Eyetech, Inc and OSI Pharmaceuticals.
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Competing interests MT serves as a consultant and speaker for Eyetech Inc. TRF has also spoken on behalf of Eyetech, Inc.
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Patient consent Obtained.
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Ethics approval The study protocol was reviewed and approved by an institutional review board at each study site in accordance with the guidelines for the conduct of clinical research in the 1964 Declaration of Helsinki. The study is listed on www.clinicaltrials.gov (NCT00354445).
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Provenance and peer review Not commissioned; externally peer reviewed.
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