Wang Fenghua, Yuan Yuanzhi, Wang Ling, Ye Xiaofeng, Zhao Jingke, Shen Mengxi, Zhang Qi, Xu Ding, Qin Guoyou, Zhang Wei, Yuan Fei, Chang Qing, Zhao Peiquan, Wang Fang, Sun Xiaodong
Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China.
J Ophthalmol. 2019 Oct 10;2019:7530458. doi: 10.1155/2019/7530458. eCollection 2019.
. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. . In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. . Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (=0.344). There were no significant differences between two groups in the mean change of CRT (-159.3 m vs. -120.5 m) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (=0.066). . One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.
比较在中国新生血管性年龄相关性黄斑变性（nvAMD，包括息肉样脉络膜血管病变（PCV））患者中，单次给药和三次负荷剂量后按需（PRN）给药方案的功能和解剖学结果。在这项多中心、前瞻性、开放标签、对照、为期12个月的研究（ClinicalTrials.gov：NCT02810808）中，患者使用玻璃体内注射雷珠单抗治疗，随机（1∶1）分为单次给药+PRN组（PRN组）或三次负荷剂量+PRN组（负荷剂量组）。评估最佳矫正视力（BCVA）和中心视网膜厚度（CRT）。主要结局为BCVA的变化。非劣效性界限为5个字母。PRN组45例患者和负荷剂量组49例患者完成了12个月的随访。每组包括4例PCV患者。PRN组BCVA较基线的平均变化为7.8个字母，而负荷剂量组为10.9个字母（P=0.344）。在第12个月时，两组CRT的平均变化（-159.3μm对-120.5μm）无显著差异。12个月随访期间的平均注射次数，PRN组为6.0次，负荷剂量组为6.8次。视力提高15个或更多字母的患者比例，PRN组为28.9%，负荷剂量组为44.9%（P=0.066）。在中国nvAMD和PCV患者中，单次给药+PRN方案使用雷珠单抗显示出不劣于三次负荷剂量+PRN方案的视力改善。PRN组的注射次数与负荷剂量组相似，但在使用OCT引导再治疗标准的一年随访期间，仍存在视力不稳定的潜在风险。本试验已在NCT02810808注册。
