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DGDispatch
Pegaptanib Maintains Visual Outcomes in Age-Related Macular Degeneration After Vascular Endothelial Growth Factor Inhibition: Presented at AAO
By Emma Hitt, PhD
ATLANTA -- November 12, 2008 -- Pegaptanib administered every 6 weeks for 1 year appears to maintain outcomes after initial vascular endothelial growth factor (VEGF) inhibition with bevacizumab or ranibizumab in patients with neovascular age-related macular degeneration (AMD), according to research presented at the American Academy of Ophthalmology (AAO) annual meeting.
Lead investigator Thomas R. Friberg, MD, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, presented findings on November 11 from the Evaluation of Efficacy and Safety in Maintaining Visual Acuity With Sequential Treatment of Neovascular AMD (LEVEL) trial.
The LEVEL trial sought to evaluate the ability of pegaptanib to sustain visual-acuity gains after induction treatment with pan-VEGF inhibitors (such as bevacizumab and ranibizumab) in neovascular AMD. "Such a strategy might be particularly relevant in patients with a history of stroke or myocardial infarction, so that their systemic exposure to pan-VEGF inhibitors can be limited," Dr. Friberg noted here during an Original Paper Session.
Pegaptanib 0.3 mg was given every 6 weeks for 1 year after successful treatment with prior therapy. Prior therapy included bevacizumab in 36% of patients, ranibizumab in 42% of patients, and multiple agents in 19% of patients. Other agents were used in 2%. The mean number of treatments given during the induction phase was 2.6.
During the maintenance phase, patients received pegaptanib, and additional booster therapy could be given at the discretion of the treating investigator. Of the 568 patients, 88% completed 1 year of maintenance with pegaptanib. Half of the subjects did not receive booster treatment during the maintenance phase. Of those who did receive booster therapy, 46% received only 1 booster.
Visual acuity increased from 49.6 letters to 65.5 letters during induction therapy and was maintained during treatment with pegaptanib; at week 54, visual acuity was 61.6 letters. Approximately 41% of patients gained at least 3 lines of visual acuity from preinduction to week 54, and 79% gained at least some visual acuity.
Centre-point thickness was maintained with pegaptanib, increasing only slightly from 191 mcm at baseline to 211 mcm at week 54.
"No differences were observed during the maintenance phase in patients treated with bevacizumab compared to ranibizumab during induction phase," Dr. Friberg noted.
Pegaptanib appeared safe. There was no evidence of an increased risk of hypertension, nonocular haemorrhages, or cardiovascular or thromboembolic events. In addition, no increase in the risk of endophthalmitis, retinal detachment, or traumatic cataract was observed.
"Treating patients earlier -- before destruction of photoreceptors or subretinal fibrosis develops -- will likely improve visual outcomes of long-term anti-VEGF therapy," Dr. Friberg said.
Funding for this study was provided by OSI Pharmaceuticals, Inc., and Pfizer Inc.
[Presentation title: Maintenance Therapy With Pegaptanib in Neovascular AMD: An Interim Analysis of the LEVEL Study. Abstract PA079]
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