Rosenfeld Philip J, Brown David M, Heier Jeffrey S, Boyer David S, Kaiser Peter K, Chung Carol Y, Kim Robert Y
Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.
N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
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.
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.
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.
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 [ClinicalTrials.gov].).
雷珠单抗——一种重组人源化单克隆抗体Fab片段，可中和血管内皮生长因子A的所有活性形式——已被用于评估治疗新生血管性年龄相关性黄斑变性。
在这项多中心、为期2年的双盲、假注射对照研究中，我们将年龄相关性黄斑变性伴最小经典型或隐匿型（无经典病变）脉络膜新生血管的患者随机分配，分别接受每月1次、共24次玻璃体内注射雷珠单抗（0.3mg或0.5mg）或假注射。主要终点是在12个月时视力较基线下降少于15个字母的患者比例。
我们共纳入716例患者进行研究。在12个月时，接受0.3mg雷珠单抗治疗的患者组中94.5%、接受0.5mg雷珠单抗治疗的患者组中94.6%的患者视力下降少于15个字母，而接受假注射的患者组中这一比例为62.2%（两组比较P均<0.001）。0.3mg组中24.8%、0.5mg组中33.8%的患者视力提高了15个及以上字母，而假注射组中这一比例为5.0%（两种剂量比较P均<0.001）。0.3mg组视力平均提高6.5个字母，0.5mg组提高7.2个字母，而假注射组视力下降10.4个字母（两组比较P均<0.001）。视力改善在24个月时仍得以维持。在24个月期间，接受雷珠单抗治疗的患者中有5例（1.0%）发生疑似眼内炎，6例（1.3%）发生严重葡萄膜炎。
对于年龄相关性黄斑变性继发的最小经典型或隐匿型（无经典病变）脉络膜新生血管患者，玻璃体内注射雷珠单抗2年可预防视力丧失并提高平均视力，严重不良事件发生率较低。（临床试验注册号，NCT00056836 [ClinicalTrials.gov]。）
