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初治的新生血管性年龄相关性黄斑变性的高剂量阿柏西普治疗

High dose aflibercept treatment in naive neovascular age-related macular degeneration.

作者信息

Acar Nur, Pehlivanoğlu Seren

机构信息

School of Medicine, Yeni Yüzyıl University, Istanbul, Turkey.

Beyoglu Eye Training and Research Hospital, University of Health Sciences, Bereketzade Camii Sk. No:2 Beyoğlu, 34421, Istanbul, Turkey.

出版信息

Int Ophthalmol. 2025 Jan 20;45(1):24. doi: 10.1007/s10792-025-03409-5.

Abstract

BACKGROUND

To evaluate the efficacy and safety of intravitreal injections of 4 mg (high dose) of aflibercept in treatment-naive patients with neovascular AMD(nAMD) with treat and extend(TREX) dosing regimens, and to determine the frequency of injections.

METHODS

In this interventional, retrospective study a total of 15 eyes of 14 patients (eight female and 9 male) with nAMD were included. All patients were examined and OCT imaging was performed at the time of initial presentation, on the day of each injection and at subsequent follow-up visits. Each eye received intravitreal injections of 4 mg/0.1 mL aflibercept at the dose of every 4 weeks for three months (loading phase) after that 4 mg high dose of aflibercept was applied as the TREX regime. The eyes with a minimum follow-up time of 12 months are included.

RESULTS

The mean age of the patients was 74.9 ± 7.3(61-85) years and the mean follow-up time was 20.33 ± 8.7(12-34) months. Total number of injections were 9.3 ± 3.0 (5-14) during the follow-up period. A statistically significant increase was found in terms of best-corrected visual acuity and central macular thickness between mean baseline values and at 1, 3, 6, 12 months, and the final examination(p < 0.05 for each comparison). No complication was observed during follow-up.

CONCLUSIONS

High-dose Aflibercept of 4 mg/0.1 mL application with the TREX regimen was found to be efficient and safe. High-dose may also help to reduce the frequency of injections and visits in the follow-up period in eyes with nAMD. Prospective studies with large series are warranted.

摘要

背景

评估玻璃体内注射4毫克(高剂量)阿柏西普,采用治疗与延长(TREX)给药方案,对初治新生血管性年龄相关性黄斑变性(nAMD)患者的疗效和安全性,并确定注射频率。

方法

在这项干预性回顾性研究中,纳入了14例(8例女性和9例男性)nAMD患者的15只眼。所有患者在初次就诊时、每次注射当天及后续随访时均接受检查并进行光学相干断层扫描(OCT)成像。每只眼在最初三个月(负荷期)每4周接受一次玻璃体内注射4毫克/0.1毫升阿柏西普,之后采用4毫克高剂量阿柏西普的TREX方案。纳入随访时间至少为12个月的眼睛。

结果

患者的平均年龄为74.9±7.3(61 - 85)岁,平均随访时间为20.33±8.7(12 - 34)个月。随访期间注射总数为9.3±3.0(5 - 14)次。在平均基线值与1、3、6、12个月及最终检查时,最佳矫正视力和中心黄斑厚度均有统计学显著增加(每次比较p < 0.05)。随访期间未观察到并发症。

结论

发现采用TREX方案应用4毫克/0.1毫升高剂量阿柏西普是有效且安全的。高剂量还可能有助于减少nAMD患者随访期间的注射频率和就诊次数。有必要开展大样本的前瞻性研究。

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