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| |  Pegaptanib Maintenance Therapy May Reduce Systemic Risk Factors for Patients With Macular Degeneration: Presented at ARVO By Cameron Johnston FT. LAUDERDALE, Fla -- May 8, 2009 -- Pegaptanib sodium is effective as a maintenance treatment for age-related macular degeneration -- and the improvements in visual acuity it provides can be maintained for more than a year following induction therapy, according to research from a large multi-centre, phase 4 study presented here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. These results may mean that the risk of certain adverse events could be reduced when using pegaptanib as opposed to other nonselective vascular endothelial growth factor (VEGF) inhibitors. The rationale for maintenance therapy with pegaptanib derives from a concern over vascular endothelial growth factor inhibitors, which act on all isoforms of the molecule (pan-VEGF inhibitors). VEGF inhibitors, including both bevacizumab and ranibizumab, have been associated with cardiac adverse events in some patients, according to lead investigator Mauro Goldbaum, MD, who presented the study results on May 4. Dr. Goldbaum was an employee of Eyetech Inc, maker of pegaptanib, when the study was conducted. He is now in private practice in São Paulo, Brazil. In the current study, patients who had choroidal neovascularisation secondary to age-related macular degeneration and who had received at least 1 prior treatment of any kind (induction therapy) were offered pegaptanib every 6 weeks for a total of 54 weeks. During the postinduction period, patients were allowed to receive other treatments at the investigator's discretion. In all, 568 patients at 87 different centres in the United States received treatment prior to the start of the open-label trial. Over the next year, patients received a total of 4,254 injections (a mean of 8 injections of pegaptanib per patient). Efficacy data showed an improvement in visual acuity from a mean of 49.6 Early Treatment Diabetic Retinopathy Study letters at baseline to 61.1 letters at 54 weeks follow-up. Forty-one percent of patients gained at least 3 lines of visual acuity at week 54. The side-effect profile was less impressive, but nonetheless, Dr. Goldbaum said it was not a cause for concern. Eighty-one percent of subjects had at least 1 adverse event, and 62% had at least 1 ocular adverse event. Twenty percent (n = 112) had at least 1 serious adverse event. Ocular adverse events included 2 cases of endophthalmitis, 2 cases of vitreous haemorrhage, and 1 case each of retinal haemorrhage, retinal tear, conjunctival irritation, and 1 vitreous opacity. Other ocular adverse events included 13% of patients with punctuate keratitis, 11% with eye pain, 10% with vitreous floaters, and 5% with macular degeneration. Dr. Goldbaum pointed out that many of the systemic events occurred in patients with pre-existing conditions; for example, 37% of subjects at enrolment already had heart disease. This study is important, Dr. Goldbaum said, because pegaptanib may be a safer alternative compared with other pan-VEGF inhibitors, which are believed to be associated with a worse adverse-event profile. Those drugs inhibit all isoforms of VEGF, whereas pegaptanib inhibits only the 165 isoform. Dr. Goldbaum concluded that the use of pegaptanib as maintenance therapy for these patients with macular degeneration proved safe and effective, with little risk of serious systemic or ocular adverse events.
[Presentation title: Interim 1-Year Safety Results of the LEVEL Study: Maintenance Therapy With Pegaptanib Sodium (Macugen) in Patients With Neovascular AMD. Abstract 1912-A602]
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