玻璃体内双剂量conberept注射治疗新生血管性年龄相关性黄斑变性:一项实验性临床实践研究。

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-08-25 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S540363
Tianwei Qian, Yanping Zhou, Hao Zhou, Wenshu Wu, Yuanzhi Yuan, Suqin Yu, Xun Xu
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引用次数: 0

摘要

目的:评价conberept单剂量(0.5 mg)和双剂量(1.0 mg)治疗新生血管性年龄相关性黄斑变性(nAMD)的疗效和安全性。方法:nAMD患者随机分为1.0 mg组和0.5 mg组。1.0 mg组前3个月每月1次玻璃体内注射1.0 mg conberept,随后进行新生方案(3+PRN)。0.5 mg组在整个治疗期间接受3+PRN方案的玻璃体内0.5 mg概念。比较两组患者在1个月、3个月、6个月和12个月随访时最佳矫正视力(BCVA)、黄斑中心厚度(CMT)和最大色素上皮脱离(PED)高度的变化。结果:33例患者完成研究,其中0.5 mg组16例,平均年龄74.00±8.23岁;1.0 mg组17例,平均年龄72.29±6.47岁。在3个月时,1.0 mg组的BCVA改善显著高于0.5 mg组(P = 0.0450),但在其他时间点没有观察到差异。在任何随访点,CMT减少均无统计学差异。关于PED高度降低,在1个月的随访中观察到显著差异(P = 0.0345),但在3、6、12个月的随访中没有观察到显著差异。黄斑干燥后,1.0 mg组液体复发时间明显长于0.5 mg组(P = 0.0360)。两组均未报告相关不良事件。结论:虽然1.0 mg组在3个月时有短暂但显著的BCVA改善,且复发间隔较长,但需要进一步的大规模试验来验证这些初步发现。试验注册:本研究已在中国临床试验注册中心注册(http://www.chictr.org.cn/, ChiCTR2000029503)。报名日期:2020年2月3日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Intravitreal Double-Dose Conbercept Injection for the Treatment of Neovascular Age-Related Macular Degeneration: A Pilot Real-Life Clinical Practice Study.

Intravitreal Double-Dose Conbercept Injection for the Treatment of Neovascular Age-Related Macular Degeneration: A Pilot Real-Life Clinical Practice Study.

Intravitreal Double-Dose Conbercept Injection for the Treatment of Neovascular Age-Related Macular Degeneration: A Pilot Real-Life Clinical Practice Study.

Intravitreal Double-Dose Conbercept Injection for the Treatment of Neovascular Age-Related Macular Degeneration: A Pilot Real-Life Clinical Practice Study.

Purpose: 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).

Methods: 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.

Results: 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 (P = 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 (P = 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 (P = 0.0360). No related adverse event was reported in either group.

Conclusion: 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.

Trial registration: This study was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/, ChiCTR2000029503). Registration date: 03/02/2020.

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