Peking University People's Hospital, Beijing, China.
China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai, China.
Acta Ophthalmol. 2021 May;99(3):e336-e345. doi: 10.1111/aos.14588. Epub 2020 Dec 30.
To evaluate the efficacy and safety of monthly and pro re nata (PRN, guided by visual acuity stabilization and disease activity criteria) ranibizumab regimens in Chinese patients with neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV).
This double-masked study randomized nAMD patients (1:1) to ranibizumab monthly from baseline to Month (M) 11 to a PRN regimen from M12 to M23 (monthly group, n = 167) versus ranibizumab three monthly doses followed by a PRN regimen up to M23 (PRN group, n = 166). Subgroups were assessed based on the presence/absence of PCV (indicated by indocyanine green angiography).
Of 334 randomized patients, 41.7% had PCV at baseline. Mean average best-corrected visual acuity (BCVA) change from M3 to M4 through M12 was 3.3 letters with monthly and 1.7 letters with PRN (mean difference: 1.6; 95% CI: -2.95, -0.20, primary end-point). Mean change in BCVA from baseline (monthly/PRN, 53.8/53.7) to M12 and M24 was 12.3 and 11.3 letters in monthly and 9.6 and 9.3 letters in PRN group. Corresponding values for patients with PCV/without PCV were 12.7/12.1 letters (M12) and 12.3/10.6 letters (M24) in monthly and 9.4/9.4 letters (M12) and 9.7/8.7 letters (M24) in PRN groups. The mean number of injections was 11.4 (monthly) and 8.2 (PRN) from Day 1 to M11 and 4.8 (monthly) and 5.0 (PRN) from M12 to M23. No new safety findings were reported.
The study results support the use of either ranibizumab monthly or PRN regimens in Chinese patients with nAMD, regardless of presence of PCV.
评估每月和按需（根据视力稳定和疾病活动标准指导）雷珠单抗方案治疗中国新生血管性年龄相关性黄斑变性（nAMD）和息肉状脉络膜血管病变（PCV）患者的疗效和安全性。
这项双盲研究将 nAMD 患者（1:1）随机分为雷珠单抗每月治疗从基线至第 11 个月，然后从第 12 个月至第 23 个月进行按需治疗（每月组，n=167），或雷珠单抗每 3 个月治疗一次，然后进行按需治疗，直至第 23 个月（PRN 组，n=166）。根据是否存在 PCV（通过吲哚青绿血管造影确定）对亚组进行评估。
在 334 名随机患者中，41.7%的患者在基线时存在 PCV。从第 3 个月至第 4 个月，每月组和 PRN 组平均最佳矫正视力（BCVA）的平均变化分别为 3.3 个字母和 1.7 个字母（平均差异：1.6；95%置信区间：-2.95，-0.20，主要终点）。从基线（每月/PRN，53.8/53.7）到第 12 个月和第 24 个月，每月组和 PRN 组 BCVA 的平均变化分别为 12.3 个和 11.3 个字母。在每月组和 PRN 组中，有 PCV/无 PCV 的患者的相应值分别为 12.7 个和 12.1 个字母（第 12 个月）和 12.3 个和 10.6 个字母（第 24 个月）。从第 1 天至第 11 个月，每月组和 PRN 组的平均注射次数分别为 11.4 次和 8.2 次，从第 12 个月至第 23 个月，每月组和 PRN 组的平均注射次数分别为 4.8 次和 5.0 次。没有报告新的安全性发现。
研究结果支持中国 nAMD 患者使用每月或按需雷珠单抗方案，无论是否存在 PCV。
