XTEND：一项关于新生血管性年龄相关性黄斑变性中玻璃体内注射阿柏西普主动给药的全球观察性研究的两年结果。
XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration.
作者信息
Korobelnik Jean-François, Chaudhary Varun, Mitchell Paul, Kang Se Woong, Tadayoni Ramin, Allmeier Helmut, Lee JinKyung, Zhang Xin, Machewitz Tobias, Bailey Clare
机构信息
Service d'Ophtalmologie, CHU Bordeaux, Bordeaux, France.
University of Bordeaux, INSERM, BPH, UMR1219, Place Amélie Raba Léon, 33000, Bordeaux, France.
出版信息
Ophthalmol Ther. 2024 Mar;13(3):725-738. doi: 10.1007/s40123-023-00867-x. Epub 2024 Jan 10.
INTRODUCTION
XTEND (NCT03939767) is a multicenter, observational, prospective study of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in routine clinical practice. The study aims to examine treatment outcomes of proactive intravitreal aflibercept (IVT-AFL) treatment regimens (fixed dosing or treat-and-extend) according to local marketing labels.
METHODS
Study eyes received IVT-AFL injections as per the local label. The mean changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month (M) 12 and M24 were measured and stratified by baseline factors. Treatment exposure and safety data were evaluated. Statistical analysis was descriptive.
RESULTS
Overall, 1466 patients from 17 countries were treated. For the overall population, the mean ± standard deviation (SD) age was 78.7 ± 8.5 (range 50-100) years, and 891 patients (60.8%) were female. The mean ± SD baseline BCVA was 54.3 ± 20.3 letters and CST was 374 ± 126 µm. At M12 and M24, mean (95% confidence interval [CI]) BCVA change was + 4.3 (3.4, 5.3) and + 2.3 (1.3, 3.3) letters, respectively. Mean (95% CI) CST was - 106 (- 114, - 99) μm and - 109 (- 117, - 102) μm at M12 and M24, respectively. At M24, 41.5% of patients had a BCVA ≥ 70 letters. Patients received a mean ± SD of 7.7 ± 2.7 injections by M12 and 10.8 ± 5.0 injections by M24 (3.1 injections between M12 and M24). Adverse events were consistent with the known safety profile of IVT-AFL.
CONCLUSION
The 24-month results indicate that, in routine clinical practice, a proactive IVT-AFL regimen achieves functional improvements in patients with treatment-naïve nAMD. The proportion of patients achieving ≥ 70 letters at M24 increased, and patients with baseline BCVA ≥ 70 letters maintained vision regardless of the followed IVT-AFL label.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03939767. A video abstract is available for this article. Supplementary file2 (MP4 364624 KB).
引言
XTEND（NCT03939767）是一项多中心、观察性、前瞻性研究，针对常规临床实践中未经治疗的新生血管性年龄相关性黄斑变性（nAMD）患者。该研究旨在根据当地市场标签检查主动玻璃体腔内注射阿柏西普（IVT-AFL）治疗方案（固定剂量或治疗并延长）的治疗效果。
方法
研究眼按照当地标签接受IVT-AFL注射。测量从基线到第12个月（M）和第24个月最佳矫正视力（BCVA）和中心子野厚度（CST）的平均变化，并按基线因素进行分层。评估治疗暴露情况和安全性数据。统计分析为描述性分析。
结果
总体而言，来自17个国家的1466例患者接受了治疗。对于总体人群，平均年龄±标准差（SD）为78.7±8.5（范围50-100）岁，891例患者（60.8%）为女性。平均±SD基线BCVA为54.3±20.3字母，CST为374±126μm。在第12个月和第24个月时，平均（95%置信区间[CI]）BCVA变化分别为+4.3（3.4，5.3）和+2.3（1.3，3.3）字母。在第12个月和第24个月时平均（95%CI）CST分别为-106（-114，-99）μm和-109（-117，-102）μm。在第24个月时，41.5%的患者BCVA≥70字母。到第12个月时患者平均接受±SD为7.7±2.7次注射，到第24个月时为10.8±5.0次注射（第12个月至第24个月期间注射3.1次）。不良事件与IVT-AFL已知的安全性特征一致。
结论
24个月的结果表明，在常规临床实践中，主动IVT-AFL方案可使未经治疗的nAMD患者在功能上得到改善。在第24个月时达到≥70字母的患者比例增加，且基线BCVA≥70字母的患者无论遵循何种IVT-AFL标签均能维持视力。
试验注册
ClinicalTrials.gov标识符：NCT03939767。本文有视频摘要。补充文件2（MP4 364624 KB）。
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