Ranibizumab for neovascular age-related macular degeneration
Ranibizumab for neovascular age-related macular degeneration
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DOI：
10.1056/nejmoa054481
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发表时间：
2006-10-05
影响因子：
158.5
通讯作者：
Kim, Robert Y.
中科院分区：
文献类型：
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作者：
Rosenfeld, Philip J.;Brown, David M.;Kim, Robert Y.
背景资料：雷珠单抗是一种重组人源化单克隆抗体Fab，可中和所有活性形式的血管内皮生长因子A，已被评估用于治疗新生血管性年龄相关性黄斑变性。在这项为期2年的多中心、双盲、假手术对照研究中，我们将年龄相关性黄斑变性患者随机分为轻度经典型和隐匿型，（无典型病变）脉络膜新生血管形成的患者接受24个月的雷珠单抗（0.3 mg或0.5 mg）玻璃体内注射或假注射。主要终点是患者在12个月时从基线视力丧失少于15个字母的比例。在12个月时，给予0.3 mg雷珠单抗的患者中有94.5%和给予0.5 mg雷珠单抗的患者中有94.6%丢失了少于15个字母，而接受假注射的患者中有62.2%丢失了少于15个字母（两种比较均P < 0.001）。与假注射组的5.0%相比，0.3 mg组的24.8%和0.5 mg组的33.8%的患者视力改善了15个或更多字母（两种剂量的P < 0.001）。0.3 mg组和0.5 mg组视力平均增加6.5个字母，而假注射组视力平均减少10.4个字母（两组比较P < 0.001）。视力方面的获益维持在24个月。在24个月期间，在5名患者中确定了假定的眼内炎严重葡萄膜炎6例（1.3%）给予雷珠单抗。玻璃体内给予雷珠单抗2年可预防视力丧失并改善平均视力，严重不良事件发生率低，继发于年龄相关性黄斑变性的最低程度经典或隐匿性（无经典病变）脉络膜新生血管形成患者。（ClinicalTrials.gov编号，NCT 00056836。）
Background: Ranibizumab - a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A - has been evaluated for the treatment of neovascular age-related macular degeneration.Methods: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months.Results: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P < 0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P < 0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P < 0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab.Conclusions: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836.)