Pegaptanib for neovascular age-related macular degeneration
Pegaptanib for neovascular age-related macular degeneration
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DOI：
10.1056/nejmoa042760
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发表时间：
2004-12-30
影响因子：
158.5
通讯作者：
Guyer, DR
中科院分区：
文献类型：
--
作者：
Gragoudas, ES;Adamis, AP;Guyer, DR
背景：培加他尼，一种抗血管内皮生长因子治疗，在治疗新生血管性年龄相关性黄斑degeneration.METHODS：我们进行了两个同时，前瞻性，随机，双盲，多中心，剂量范围，对照临床试验，采用广泛的进入标准。在48周的时间内，每6周一次向每例患者的一只眼玻璃体内注射哌加他尼（剂量为0.3 mg、1.0 mg或3.0 mg）或假注射。主要终点是54周时视力丧失少于15个字母的患者比例。结果：在主要终点的综合分析中（共1186例患者），三种剂量的哌加他尼均显示了疗效，无剂量-反应关系（P
BACKGROUND:Pegaptanib, an anti-vascular endothelial growth factor therapy, was evaluated in the treatment of neovascular age-related macular degeneration.METHODS:We conducted two concurrent, prospective, randomized, double-blind, multicenter, dose-ranging, controlled clinical trials using broad entry criteria. Intravitreous injection into one eye per patient of pegaptanib (at a dose of 0.3 mg, 1.0 mg, or 3.0 mg) or sham injections were administered every 6 weeks over a period of 48 weeks. The primary end point was the proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks.RESULTS:In the combined analysis of the primary end point (for a total of 1186 patients), efficacy was demonstrated, without a dose-response relationship, for all three doses of pegaptanib (P