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| |  Study Demonstrates Efficacy of Maintenance Dosing Pegaptanib for Macular Degeneration: Presented at RC2009 By Cameron Johnston NEW YORK -- October 7, 2009 -- A novel trial designed to test whether it might be beneficial to initiate a patient with age-related macular degeneration (AMD) on 1 drug, then switch the patient to another drug midway through the course of therapy seems to be proving its intended hypothesis. Pamela Ann Weber, MD, Department of Ophthalmology, Stony Brook University Medical Center, Stony Brook, New York, presented the findings on October 3 here at the Retina Congress (RC) 2009. The Evaluation of Efficacy and Safety in Maintaining Visual Acuity With Sequential Treatment of Neovascular AMD (LEVEL) was a prospective, uncontrolled, open-label study involving 568 patients whose AMD would be treated initially with monthly doses of intravitreal ranibizumab 0.5 mg or bevacizumab 1.25 mg. After at least 1, but not more than 3 injections, if significant improvements in anatomical and functional outcomes were verified, patients were then switched to a maintenance regimen of pegaptanib 0.3 mg administered every 6 weeks, for a total of 48 weeks. The rationale for this trial design stems from the fact that ranibizumab and bevacizumab block all isoforms of vascular endothelial growth factor (pan-VEGF blockers). Some small studies have suggested that blocking all isoforms of VEGF may have detrimental effects on the heart and circulatory system, as well as on the body’s ability to heal itself in the event of surgery or an injury. On the other hand, pegaptanib sodium blocks only the VEGF165 isoform, and therefore, may have less of a systemic impact than the other 2 drugs. During the induction phase, bevacizumab was given to 207 patients (36%), ranibizumab was given to 241 patients (42%), and 107 patients (19%) received multiple agents. Patients received a mean of 2.6 treatments each. During the follow-up, maintenance phase, booster therapies were given to 52% of patients over the entire study, and of those, 46% needed only 1 additional injection. The mean length of time between baseline and the first booster injection was 147 days. There was a mean improvement in visual acuity (VA) from the induction phase and throughout the 54-week study, indicating that pegaptanib was beneficial as maintenance therapy. At baseline, the mean VA was 49.6 ETDRS letters, which increased to 65.5 letters when the maintenance phase began. The final mean VA after 54 weeks was 61.8 letters. Over the 54-week period, 41% of patients gained >=3 lines of VA and 79% gained at least some VA. In total, only 8% of patients lost vision during the study. Specifically, among patients who were treated with ranibizumab, mean VA improved from 50.7 letters at enrolment, to 65.9 letters at the end of the induction phase. The benefit was maintained out to 54 weeks, where the final mean VA was 63.1 letters. The authors concluded that overall, the patients showed visual and anatomical stability throughout the maintenance phase of the study and that maintenance dosing with pegaptanib may reduce the patient’s exposure to either ranibizumab or bevacizumab, and therefore, presents a safe and effective alternative to those pan-VEGF agents. The 2009 Retina Congress is a combined meeting of the American Society of Retina Specialists, the Macula Society, and the Retina Society. [Presentation title: Subgroup Analysis of the 1-year Efficacy and Safety of Maintenance Therapy With Pegaptanib Sodium in Neovascular AMD (NV-AMD): The LEVEL Study. Abstract 780]
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