title: Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study.
abstract: OBJECTIVE
  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.
authors.affiliation: Ophthalmology, University of Pittsburgh Medical Center Eye Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. friberg@pitt.edu
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Friberg
authors.forename: Michael
authors.initials: M
authors.lastname: Tolentino
authors.forename: Pamela
authors.initials: P
authors.lastname: Weber
authors.forename: Sunil
authors.initials: S
authors.lastname: Patel
authors.forename: Scott
authors.initials: S
authors.lastname: Campbell
authors.forename: Mauro
authors.initials: M
authors.lastname: Goldbaum
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D052157:Aptamers, Nucleotide / Q000627:therapeutic use*; D003315:Cornea / Q000098:blood supply*; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology*; D057135:Wet Macular Degeneration / Q000188:drug therapy / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D052157:Aptamers, Nucleotide; D042461:Vascular Endothelial Growth Factor A; C495058:pegaptanib
references.citation: Ophthalmology. 2009 Feb;116(2):362
references.pmid: 19187826
references.citation: Ophthalmic Surg Lasers Imaging. 2008 Jul-Aug;39(4):294-8
references.pmid: 18717434
references.citation: Br J Pharmacol. 2006 Jan;147 Suppl 1:S193-201
references.pmid: 16402104
references.citation: Br J Surg. 2008 May;95(5):576-81
references.pmid: 18344184
references.citation: Ophthalmic Surg Lasers Imaging. 2006 Nov-Dec;37(6):446-54
references.pmid: 17152537
references.citation: Surv Ophthalmol. 2009 May-Jun;54(3):339-48
references.pmid: 19422962
references.citation: Ophthalmology. 2007 Sep;114(9):1702-12
references.pmid: 17509689
references.citation: Am J Ophthalmol. 2009 Jul;148(1):43-58.e1
references.pmid: 19376495
references.citation: Br J Ophthalmol. 2008 Dec;92(12):1606-11
references.pmid: 18614570
references.citation: Am J Ophthalmol. 2007 Jun;143(6):995-1002
references.pmid: 17449002
references.citation: N Engl J Med. 2004 Dec 30;351(27):2805-16
references.pmid: 15625332
references.citation: N Engl J Med. 2006 Oct 5;355(14):1419-31
references.pmid: 17021318
references.citation: Ophthalmology. 2009 Sep;116(9):1731-9
references.pmid: 19643495
references.citation: Nat Rev Cancer. 2007 Jun;7(6):475-85
references.pmid: 17522716
references.citation: Blood. 1997 Apr 1;89(7):2429-42
references.pmid: 9116287
references.citation: N Engl J Med. 2006 Oct 5;355(14):1432-44
references.pmid: 17021319
references.citation: N Engl J Med. 2007 Feb 15;356(7):748-9; author reply 749-50
references.pmid: 17310523
references.citation: Am J Pathol. 2007 Jul;171(1):53-67
references.pmid: 17591953
references.citation: Invest Ophthalmol Vis Sci. 2009 Oct;50(10):4982-91
references.pmid: 19357355
references.citation: Ann Pharmacother. 2007 Apr;41(4):614-25
references.pmid: 17355998
references.citation: Microvasc Res. 2001 Sep;62(2):179-89
references.pmid: 11516247
references.citation: Retina. 2006 Oct;26(8):859-70
references.pmid: 17031284
references.citation: Ophthalmology. 2009 Sep;116(9):1755-61
references.pmid: 19560206
references.citation: Oncology. 2005;69 Suppl 3:25-33
references.pmid: 16301833