Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.
Ophthalmology. 2013 May;120(5 Suppl):S8-10. doi: 10.1016/j.ophtha.2013.01.058.
Discussion of Comparisons of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT) results and the potential impact on neovascular AMD treatment.
Ranibizumab and bevacizumab are most commonly used for treatment of neovascular AMD. Although bevacizumab costs less, its use primarily has been based on retrospective studies without level 1 medical evidence. Thus, there was an unmet need to determine whether there is any difference in efficacy and safety between the 2 agents when used monthly or as needed (pro re nata [PRN]).
Review of CATT (focusing on 1-year data because 2-year data were not released at the time of this symposium), a randomized clinical trial evaluating the efficacy and safety of monthly and PRN dosing of ranibizumab and bevacizumab.
At the 1-year primary end point, eyes that received monthly ranibizumab gained an average of 8.5 letters; those that received monthly bevacizumab gained a mean of 8 letters. Eyes randomized to PRN ranibizumab gained an average of 6.8 letters; those randomized to PRN bevacizumab gained a mean of 5.9 letters. In the pairwise comparisons, PRN bevacizumab compared with monthly bevacizumab and PRN bevacizumab compared with monthly ranibizumab both were found to be inconclusive. At the 2-year end point, eyes that received monthly ranibizumab gained an average of 8.8 letters; those that received monthly bevacizumab gained a mean of 7.8 letters; those randomized to PRN ranibizumab gained an average of 6.7 letters; those randomized to PRN bevacizumab gained a mean of 5 letters. A higher rate of serious systemic adverse events also was detected among bevacizumab-treated subjects.
The CATT demonstrated that PRN ranibizumab is equivalent to monthly ranibizumab at the 1-year primary outcome. Monthly bevacizumab also is equivalent to monthly ranibizumab at the 1-year end point. The 2-year data showed less visual acuity gain with PRN dosing of either drug than monthly dosing.
标题：比较年龄相关性黄斑变性（AMD）治疗试验（CATT）结果及其对新生血管性 AMD 治疗的潜在影响的讨论
临床相关性：雷珠单抗和贝伐单抗是治疗新生血管性 AMD 最常用的药物。虽然贝伐单抗的成本较低，但它的使用主要基于回顾性研究，没有一级医学证据。因此，需要确定在每月或按需（即按需治疗[PRN]）使用这两种药物时，它们在疗效和安全性方面是否存在差异。
方法：对 CATT（重点关注 1 年数据，因为在本次研讨会召开时，2 年数据尚未公布）进行回顾，这是一项评估雷珠单抗和贝伐单抗每月和 PRN 剂量的疗效和安全性的随机临床试验。
结果：在 1 年的主要终点时，接受每月雷珠单抗治疗的眼睛平均增加了 8.5 个字母；接受每月贝伐单抗治疗的眼睛平均增加了 8 个字母。随机接受 PRN 雷珠单抗治疗的眼睛平均增加了 6.8 个字母；随机接受 PRN 贝伐单抗治疗的眼睛平均增加了 5.9 个字母。在两两比较中，PRN 贝伐单抗与每月贝伐单抗比较和 PRN 贝伐单抗与每月雷珠单抗比较均无定论。在 2 年终点时，接受每月雷珠单抗治疗的眼睛平均增加了 8.8 个字母；接受每月贝伐单抗治疗的眼睛平均增加了 7.8 个字母；随机接受 PRN 雷珠单抗治疗的眼睛平均增加了 6.7 个字母；随机接受 PRN 贝伐单抗治疗的眼睛平均增加了 5 个字母。贝伐单抗治疗组还检测到更高的严重全身不良事件发生率。
结论：CATT 表明，在 1 年主要结局时，PRN 雷珠单抗与每月雷珠单抗等效。每月贝伐单抗在 1 年终点时也与每月雷珠单抗等效。2 年数据显示，与每月给药相比，两种药物的 PRN 给药视力提高幅度较小。
