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根据英国许可,按固定间隔接受阿柏西普治疗的新生血管性年龄相关性黄斑变性患者的真实世界视觉结局。

Real-world visual outcomes in patients with neovascular age-related macular degeneration receiving aflibercept at fixed intervals as per UK licence.

机构信息

Department of Ophthalmology, Royal Free London NHS Foundation Trust, London, UK.

Macular Research Group, Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Clin Exp Ophthalmol. 2018 May;46(4):407-411. doi: 10.1111/ceo.13085. Epub 2017 Nov 16.

Abstract

IMPORTANCE

To assess the impact of injection frequency on visual outcomes in patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept.

BACKGROUND

The UK licence for treatment of nAMD with aflibercept is based on the VIEW protocol. We tested the hypothesis that patients receiving fewer than the eight recommended injections in the first year would experience worse visual outcomes.

DESIGN

Retrospective, single-centre observational study.

PARTICIPANTS

There were 42 eyes from 42 patients included.

METHODS

Fight Retinal Blindness! software was used to record real-world outcomes of all treatment-naïve eyes receiving aflibercept for at least 1 year.

MAIN OUTCOME MEASURES

Visual acuity (VA) at 1 year in eyes which received the recommended eight injections versus those receiving seven or fewer injections.

RESULTS

There were 21 eyes (50%) that received the recommended eight aflibercept injections in the first year of treatment, whilst 14 eyes received seven injections, five received six injections and two received only five injections, with median VA change +7.0, +5.0, -4.0 and -6.5 LogMAR letters, respectively. Those eyes receiving seven or fewer injections had worse baseline vision. The main reasons for patients being undertreated were insufficient clinic capacity and non-attendance due to illness.

CONCLUSIONS AND RELEVANCE

Patients in the real-world receiving aflibercept for nAMD at fixed intervals as per UK licence could achieve similar visual improvement at 1 year compared with phase III clinical trials. Undertreated patients had worse visual outcomes. Measures need to be introduced to increase clinic capacity and closely follow non-attenders to improve future outcomes.

摘要

重要性

评估注射频率对接受玻璃体内阿柏西普治疗的新生血管性年龄相关性黄斑变性(nAMD)患者视觉结局的影响。

背景

在英国,阿柏西普治疗 nAMD 的许可基于 VIEW 方案。我们检验了这样一个假设,即第一年接受少于推荐 8 次注射的患者会出现更差的视觉结局。

设计

回顾性、单中心观察性研究。

参与者

共纳入 42 名患者的 42 只眼。

方法

使用 Fight Retinal Blindness!软件记录所有接受阿柏西普治疗至少 1 年的治疗初治眼的真实世界结局。

主要观察指标

接受推荐的 8 次阿柏西普注射的眼与接受 7 次或更少注射的眼在 1 年内的视力(VA)。

结果

第一年接受推荐的 8 次阿柏西普注射的眼有 21 只(50%),而接受 7 次、6 次和 5 次注射的眼分别有 14 只、5 只和 2 只,VA 变化中位数分别为+7.0、+5.0、-4.0 和-6.5 LogMAR 字母。接受 7 次或更少注射的眼基线视力更差。患者接受不足治疗的主要原因是临床容量不足和因疾病导致的失访。

结论和相关性

在现实世界中,按照英国许可的固定间隔接受阿柏西普治疗 nAMD 的患者在 1 年内可获得与 III 期临床试验相似的视觉改善。治疗不足的患者视觉结局更差。需要采取措施增加临床容量,并密切关注失访者,以改善未来结局。

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