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康柏西普治疗湿性年龄相关性黄斑变性患者加载期后早期残余液的眼的基线特征:PRECISE 研究报告 3。

Baseline characteristics of eyes with early residual fluid post loading phase of aflibercept therapy in neovascular AMD: PRECISE study report 3.

机构信息

National Institute of Health Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, UK.

Institute of Ophthalmology, University College, London, UK.

出版信息

Eye (Lond). 2024 May;38(7):1301-1307. doi: 10.1038/s41433-023-02886-1. Epub 2023 Dec 15.

Abstract

PURPOSE

To compare the baseline characteristics in patients with and without early residual fluid (ERF) after aflibercept loading phase (LP) in patients with treatment naïve neovascular age related macular degeneration (nAMD).

METHODS

Patients with nAMD initiated on LP of three intravitreal aflibercept doses were recruited from December 2019 to August 2021. Baseline demographic and OCT features associated with any ERF were analysed using Generalised Estimating Equations to account for inter-eye correlation. Receiver operating characteristic (ROC) curve was performed for selection of CST threshold.

RESULTS

Of 2128 patients enrolled, 1999 eyes of 1862 patients with complete data were included. After LP, ERF was present in 1000 (50.0%), eSRF in 746(37.3%) and eIRF in 428 (21.4%) eyes. In multivariable analysis of baseline features, eyes with increased central subfield thickness (CST) (OR 1.31 per 100 microns increase [95% CI 1.22 to 1.41]; P < 0.001), eyes with IRF and SRF at baseline (1.62 [95% CI 1.17 to 2.22]; P = 0.003), and those with SRF only (OR 2.26 [95% CI 1.59 to 3.20]; P < 0.001) relative to IRF only were determinants of ERF. CST ≥ 418 microns had 57% sensitivity and 58% specificity to distinguish ERF from no ERF at visit 4.

CONCLUSION

On average, 50% of eyes have ERF after aflibercept LP. Clinically relevant baseline determinants of ERF include CST ≥ 418 µ and presence of only SRF. These eyes may require further monthly treatment before extending treatment intervals.

摘要

目的

比较接受阿柏西普负荷期(LP)治疗的初发性新生血管年龄相关性黄斑变性(nAMD)患者中存在和不存在早期残余液(ERF)的基线特征。

方法

2019 年 12 月至 2021 年 8 月,招募了开始接受 LP 治疗的 nAMD 患者,LP 方案为三次玻璃体内注射阿柏西普。采用广义估计方程分析与任何 ERF 相关的基线人口统计学和 OCT 特征,以解释眼间相关性。为了选择 CST 阈值,进行了接收者操作特征(ROC)曲线分析。

结果

共纳入 2128 例患者,其中 1862 例患者的 1999 只眼数据完整,纳入分析。LP 后,1000 只眼(50.0%)存在 ERF,746 只眼(37.3%)存在 eSRF,428 只眼(21.4%)存在 eIRF。多变量基线特征分析显示,中央视网膜神经纤维层厚度(CST)增加的眼(每增加 100 µm,比值比[OR]为 1.31[95%置信区间(CI)为 1.22 至 1.41];P<0.001)、基线时存在 IRF 和 SRF 的眼(OR 为 1.62[95%CI 为 1.17 至 2.22];P=0.003)和仅存在 SRF 的眼(OR 为 2.26[95%CI 为 1.59 至 3.20];P<0.001)是 ERF 的决定因素。第 4 次就诊时,CST≥418μm 对 ERF 和非 ERF 的诊断灵敏度为 57%,特异性为 58%。

结论

平均而言,阿柏西普 LP 后 50%的眼存在 ERF。与 ERF 相关的临床相关基线决定因素包括 CST≥418µm 和仅存在 SRF。这些眼可能需要在延长治疗间隔之前进一步进行每月治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8e8/11076629/6f768b37e5a6/41433_2023_2886_Fig1_HTML.jpg

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