Qian Tianwei, Zhou Yanping, Zhou Hao, Wu Wenshu, Yuan Yuanzhi, Yu Suqin, Xu Xun
Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Department of Ophthalmology, Shanghai Zhongshan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China.
Clin Ophthalmol. 2025 Aug 25;19:2965-2976. doi: 10.2147/OPTH.S540363. eCollection 2025.
To evaluate the efficacy and safety of conbercept for neovascular age-related macular degeneration (nAMD) when administered at the labeled dose (0.5 mg) and double dose (1.0 mg).
Patients with nAMD were randomized to either 1.0 mg or 0.5 mg groups. The 1.0 mg group received intravitreal injection of 1.0 mg conbercept once monthly for the first three months, followed by a pro re nata regimen (3+PRN). The 0.5 mg group received 3+PRN regimens of intravitreal 0.5 mg conbercept throughout the treatment period. Changes in best corrected visual acuity (BCVA), central macular thickness (CMT), and maximum pigment epithelial detachment (PED) height from baseline were compared between the two treatment groups at 1-, 3-, 6-, and 12-month follow-ups.
Thirty-three patients completed the study, including 16 in the 0.5 mg group with an average age of 74.00 ± 8.23 years, and 17 in the 1.0 mg group with an average age of 72.29 ± 6.47 years. At 3-month, BCVA improvement in the 1.0 mg group was significantly higher than in the 0.5 mg group ( = 0.0450), though no differences were observed at other time points. There was no statistical difference in CMT reduction at any follow-up points. Regarding PED height reduction, a significant difference was observed at the 1-month follow-up ( = 0.0345), but not at the 3-, 6-, or 12-month follow-ups. After drying the macula, the recurrence interval of fluid in the 1.0 mg group was significantly longer than in the 0.5 mg group ( = 0.0360). No related adverse event was reported in either group.
While the 1.0 mg group showed a transient but significant BCVA improvement at 3 months and a longer recurrence interval, further large-scale trials are needed to validate these preliminary findings.
This study was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/, ChiCTR2000029503). Registration date: 03/02/2020.
评估雷珠单抗以标记剂量（0.5毫克）和双倍剂量（1.0毫克）给药治疗新生血管性年龄相关性黄斑变性（nAMD）的疗效和安全性。
nAMD患者被随机分为1.0毫克组或0.5毫克组。1.0毫克组在最初三个月每月一次玻璃体内注射1.0毫克雷珠单抗，随后按需给药（3+PRN）方案。0.5毫克组在整个治疗期间接受玻璃体内0.5毫克雷珠单抗的3+PRN方案。在1、3、6和12个月随访时，比较两个治疗组最佳矫正视力（BCVA）、中心黄斑厚度（CMT）和最大色素上皮脱离（PED）高度相对于基线的变化。
33例患者完成研究，其中0.5毫克组16例，平均年龄74.00±8.23岁；1.0毫克组17例，平均年龄72.29±6.47岁。在3个月时，1.0毫克组的BCVA改善显著高于0.5毫克组（=0.0450），但在其他时间点未观察到差异。在任何随访点，CMT降低均无统计学差异。关于PED高度降低，在1个月随访时有显著差异（=0.0345），但在3、6或12个月随访时无差异。黄斑干燥后，1.0毫克组液体复发间隔显著长于0.5毫克组（=0.0360）。两组均未报告相关不良事件。
虽然1.0毫克组在3个月时显示出短暂但显著的BCVA改善和更长的复发间隔，但需要进一步的大规模试验来验证这些初步发现。
本研究在中国临床试验注册中心（http://www.chictr.org.cn/，ChiCTR2000029503）注册。注册日期：2020年02月03日。
