Ranibizumab and bevacizumab for neovascular age-related macular degeneration.
Ranibizumab and bevacizumab for neovascular age-related macular degeneration.
复制标题
DOI：
10.1056/nejmoa1102673
复制
发表时间：
2011-05-19
期刊：
影响因子：
--
通讯作者：
Jaffe GJ
中科院分区：
文献类型：
--
作者：
CATT Research Group;Martin DF;Maguire MG;Ying GS;Grunwald JE;Fine SL;Jaffe GJ
临床试验证实了雷尼比珠单抗治疗新生血管性老年性黄斑变性(AMD)的疗效。此外，贝伐单抗用于非标签治疗AMD，尽管缺乏类似的支持数据。在一项多中心、单盲、非劣势试验中，我们随机将1208名新生血管性AMD患者分配到玻璃体内注射雷尼比单抗或贝伐单抗，按月计划或根据需要进行每月评估。主要结果是1年后视力的平均变化，眼表上的非劣势限制为5个字母。每月服用贝伐单抗相当于每月服用雷尼比珠单抗，分别获得8.0和8.5个字母。贝伐单抗按需给药相当于雷尼比单抗，分别增加了5.9和6.8个字母。所需的ranibizumab相当于每月的ranibizumab，尽管在所需的贝伐单抗和每月的贝伐单抗之间的比较并不确定。雷比珠单抗月组视网膜中央厚度平均下降(196μm)大于其他组(152~168μm，经方差分析，P=0.03)。接受贝伐单抗和雷尼贝珠单抗治疗的患者死亡率、心肌梗死和中风发生率相似(P&gT；0.20)。服用贝伐单抗的患者出现严重全身不良事件(主要是住院)的比例高于服用雷尼贝珠单抗的患者(24.1%对19.0%；风险比为1.29；95%可信区间为1.01至1.66)，过量事件广泛分布在先前研究中未被确定为值得关注的疾病类别中。1年后，贝伐单抗和雷尼比珠单抗按相同的时间表给药，对视力的影响相同。根据需要给予雷尼比珠单抗，并按月评估，对视力的影响与每月给予雷尼比珠单抗的效果相当。严重不良事件发生率的差异需要进一步研究。(由国家眼科研究所资助；ClinicalTrials.gov编号，NCT00593450。)
Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data. In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a non-inferiority limit of 5 letters on the eye chart. Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P = 0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern. At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.)