Twenty-four-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-Related Macular Degeneration
Twenty-four-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-Related Macular Degeneration
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DOI：
10.1016/j.ophtha.2014.05.009
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发表时间：
2014-11-01
期刊：
影响因子：
13.7
通讯作者：
Lai, Phillip
中科院分区：
文献类型：
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作者：
Ho, Allen C.;Busbee, Brandon G.;Lai, Phillip
目的：评估玻璃体内注射雷珠单抗 0.5 mg 和 2.0 mg 每月或按需（pro re nata [PRN]）治疗新生血管性年龄相关性黄斑变性（湿性 AMD）患者的 24 个月疗效和安全性。设计：24 个月、多中心、随机、双盲、积极治疗对照 3 期试验。参与者：患者（n = 1098）> = 50 岁方法：患者随机接受玻璃体内注射雷珠单抗 0.5 mg 或 2.0 mg 每月一次或 3 个月负荷剂量后接受 PRN。 主要疗效指标：主要疗效终点是第 12 个月时最佳矫正视力 (BCVA) 相对于基线的平均变化。关键次要终点包括 24 个月时 BCVA 相对于基线的平均变化、≥1 的患者比例BCVA 中的 15 个字母、雷珠单抗注射的平均次数以及通过谱域光学相干断层扫描得出的中央凹厚度随时间相对于基线的平均变化。还对第 24 个月的眼部和全身安全事件进行了评估。 结果：第 24 个月时，BCVA 相对于基线的平均变化为（字母）+9.1（每月 0.5 mg）、+7.9（0.5 mg PRN）、+8.0（每月 2.0 mg）和 +7.6（2.0 mg PRN）。从第 12 个月到第 24 个月，平均 BCVA 的变化分别为（字母）-1.0、-0.3、-1.2 和 -1.0。第 24 个月时 BCVA 较基线增加≥ 15 个字母的患者比例分别为 34.5%、33.1%、37.6% 和 34.8%。截至第 24 个月，雷珠单抗注射的平均次数分别为 21.4、13.3、21.6 和 11.2； 0.5 mg 和 2.0 mg PRN 组在第 2 年分别需要平均注射 5.6 次和 4.3 次。 0.5 mg PRN 组在 3 个月负荷剂量后的平均治疗间隔为 9.9 周，其中 93% 的患者不需要每月给药。所有 4 个治疗组的 2 年眼部和全身安全性情况相似，并且与之前的 AMD 雷珠单抗试验一致。结论：第 24 个月时，平均 BCVA 改善具有临床意义，并且所有 4 个雷珠单抗治疗组相似。 0.5 mg PRN 组在第 24 个月时平均增加了 7.9 个字母，平均注射 13.3 次（第 2 年注射 5.6 次）。 24 个月内未发现新的安全事件。 (C) 2014 年由美国眼科学会颁发。这是一篇遵循 CC BY-NC-ND 许可证 (http://creativecommons.org/licenses/by-nc-nd/3.0/) 的开放获取文章。
Objective: To evaluate the 24-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly or as needed (pro re nata [PRN]) in patients with neovascular age-related macular degeneration (wet AMD).Design: Twenty-four-month, multicenter, randomized, double-masked, active treatment-controlled phase 3 trial.Participants: Patients (n = 1098) >= 50 years of age with treatment-naive subfoveal wet AMD.Methods: Patients were randomized to receive intravitreal injections of ranibizumab 0.5 mg or 2.0 mg monthly or PRN after 3 monthly loading doses.Main Outcome Measures: The primary efficacy end point was the mean change in best-corrected visual acuity (BCVA) from baseline at month 12. Key secondary end points included mean change in BCVA from baseline at month 24, proportion of patients who gained >= 15 letters in BCVA, mean number of ranibizumab injections, and mean change in central foveal thickness from baseline over time by spectral-domain optical coherence tomography. Ocular and systemic safety events also were evaluated through month 24.Results: At month 24, the mean change from baseline in BCVA was (letters) +9.1 (0.5 mg monthly), +7.9 (0.5 mg PRN), +8.0 (2.0 mg monthly), and +7.6 (2.0 mg PRN). The change in mean BCVA from month 12 to 24 was (letters) -1.0, -0.3, -1.2, and -1.0, respectively. The proportion of patients who gained >= 15 letters from baseline in BCVA at month 24 was 34.5%, 33.1%, 37.6%, and 34.8%, respectively. The mean number of ranibizumab injections through month 24 was 21.4, 13.3, 21.6, and 11.2, respectively; 5.6 and 4.3 mean injections were required in year 2 in the 0.5 mg and 2.0 mg PRN groups, respectively. The average treatment interval in the 0.5 mg PRN group was 9.9 weeks after 3 monthly loading doses, and 93% of these patients did not require monthly dosing. Ocular and systemic safety profiles over 2 years were similar among all 4 treatment groups and were consistent with previous ranibizumab trials in AMD.Conclusions: At month 24, mean BCVA improvements were clinically meaningful and similar among all 4 ranibizumab treatment groups. The 0.5 mg PRN group achieved a mean gain of 7.9 letters at month 24 with an average of 13.3 injections (5.6 injections in year 2). No new safety events were identified over 24 months. (C) 2014 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).