Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study.

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.

• Authors: Thomas R Friberg, Michael Tolentino, LEVEL Study Group, Pamela Weber, Sunil Patel, Scott Campbell, Mauro Goldbaum
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 94 Issue 12 Pg. 1611-7 (Dec 2010) ISSN: 1468-2079 [Electronic] England
• PMID: 20472746 (Publication Type: Clinical Trial, Phase IV, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Aptamers, Nucleotide
• Vascular Endothelial Growth Factor A
• pegaptanib

Topics

• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Aptamers, Nucleotide (therapeutic use)
• Cornea (blood supply)
• Female
• Humans
• Macular Degeneration (drug therapy, physiopathology)
• Male
• Middle Aged
• Prospective Studies
• Tomography, Optical Coherence
• Treatment Outcome
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity (physiology)
• Wet Macular Degeneration (drug therapy, physiopathology)