Ranibizumab versus verteporfin for neovascular age-related macular degeneration
Ranibizumab versus verteporfin for neovascular age-related macular degeneration
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DOI：
10.1056/nejmoa062655
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发表时间：
2006-10-05
影响因子：
158.5
通讯作者：
Schneider, Susan
中科院分区：
文献类型：
--
作者：
Brown, David M.;Kaiser, Peter K.;Schneider, Susan
背景：我们比较了雷尼比珠单抗--一种重组的、人源化的、能中和所有活性形式的血管内皮生长因子A的单抗Fab--与维替普芬的光动力疗法在治疗主要是典型的新生血管性老年性黄斑变性方面的疗效。方法：在这项为期两年的多中心双盲研究的第一年，我们按1：1：1的比例随机分配患者接受雷尼比单抗(0.3毫克或0.5毫克)加假维普芬玻璃体腔内注射或每月假注射加活性维普芬治疗。结果：在纳入的423名患者中，服用0.3 mg雷尼比单抗的患者和服用0.5 mg的患者中，94.3%的患者丢失了少于15个字母，而服用维替普芬的患者中，64.3%的患者丢失了少于15个字母(P<；每次比较P<；0.001)。与维替普芬组的5.6%相比，0.3mg组和0.5mg组的35.7%和40.3%的患者视力提高了15个字母或更多(P<；每次比较均为0.001)。平均视力在0.3毫克组和0.5毫克组分别增加了8.5%和11.3%，而服用维替普芬的患者平均视力下降了9.5%(P<；每次比较P<；0.001)。在接受0.5 mg雷比珠单抗治疗的140名患者中，2名患者(1.4%)可能发生眼内炎，1名患者(0.7%)发生严重葡萄膜炎。结论：雷尼比珠单抗玻璃体内注射治疗以典型新生血管性老年性黄斑变性为主的疗效优于维替普芬，严重眼部不良事件发生率低。治疗后视力平均提高1年。(ClinicalTrials.gov编号，NCT00061594。)
Background: We compared ranibizumab - a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A - with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration.Methods: During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months.Results: Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P < 0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P < 0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P < 0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%).Conclusions: Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594.)