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新生血管性年龄相关性黄斑变性活动性疾病延迟再治疗对预后的有害影响:RAMPS研究

Detrimental Effect of Delayed Re-treatment of Active Disease on Outcomes in Neovascular Age-Related Macular Degeneration: The RAMPS Study.

作者信息

Chong Teo Kelvin Yi, Saxena Nakul, Gan Alfred, Wong Tien Y, Gillies Mark C, Chakravarthy Usha, Gemmy Cheung Chui Ming

机构信息

Singapore Eye Research Institute, Singapore, Republic of Singapore; Singapore National Eye Centre, Singapore, Republic of Singapore; Duke-NUS Medical School, National University of Singapore, Singapore, Republic of Singapore.

Novartis Singapore Pte Ltd, Singapore, Republic of Singapore.

出版信息

Ophthalmol Retina. 2020 Sep;4(9):871-880. doi: 10.1016/j.oret.2020.03.017. Epub 2020 Apr 1.

Abstract

PURPOSE

To assess the impact of delaying anti-vascular endothelial growth factor (VEGF) treatment of active disease at any point during a patient's treatment journey on clinical outcomes in a real-world cohort of patients with neovascular age-related macular degeneration (nAMD).

DESIGN

Longitudinal cohort study.

PARTICIPANTS

Consecutive treatment-naive nAMD eyes commencing anti-VEGF monotherapy (bevacizumab, ranibizumab, or aflibercept) from January 2014 from a tertiary eye center in Singapore.

METHODS

We conducted a real-world study using registry data comparing delayed re-treatment (defined as not receiving treatment at 2 or more monitoring visits when disease was graded as active) versus timely re-treatment (defined as receiving treatment when disease was active).

MAIN OUTCOME MEASURES

The primary outcome was the change in visual acuity (VA) in the timely and delayed re-treatment groups at 12 months.

RESULTS

Data from 286 eyes were included and categorized into the timely (188 [66%]) or the delayed (98 ([34%]) group. The mean numbers of anti-VEGF injections over 12 months were similar: 5.6 (standard deviation [SD], 2.9) versus 4.9 (SD, 3.2; P = 0.11) for the timely and delayed groups, respectively. Timely treated patients showed larger gains in VA (6.4 letters [SD, 8.1 letters] vs. 1.2 letters [SD, 5.3 letters; P = 0.04), a higher proportion with VA of 6/12 or better (30% vs. 8%; P = 0.01), and greater reduction in OCT-measured central subfield thickness (135 μm [SD, 154 μm] vs. 87.8 μm [SD, 129 μm]; P = 0.04) at 12 months. A longer delay between detection of active disease and re-treatment was associated with poorer vision outcomes (0.02-letter decrease/day; P = 0.03; R = 0.29).

CONCLUSIONS

Although it has been established that adequate numbers of injections are required for favorable outcomes, timely re-treatment of active disease also is important. This should be emphasized to patients to ensure optimal outcomes in real-world clinical settings.

摘要

目的

评估在患者治疗过程中的任何时间点延迟对活动性疾病进行抗血管内皮生长因子(VEGF)治疗,对新血管性年龄相关性黄斑变性(nAMD)真实世界队列患者临床结局的影响。

设计

纵向队列研究。

参与者

2014年1月起在新加坡一家三级眼科中心开始接受抗VEGF单药治疗(贝伐单抗、雷珠单抗或阿柏西普)的初治nAMD患眼。

方法

我们利用登记数据进行了一项真实世界研究,比较延迟再治疗(定义为疾病分级为活动性时,在2次或更多次监测访视时未接受治疗)与及时再治疗(定义为疾病活动性时接受治疗)。

主要观察指标

主要结局是及时再治疗组和延迟再治疗组在12个月时的视力(VA)变化。

结果

纳入286只患眼的数据,并分为及时组(188只[66%])或延迟组(98只[34%])。12个月内抗VEGF注射的平均次数相似:及时组和延迟组分别为5.6次(标准差[SD],2.9)和4.9次(SD,3.2;P = 0.11)。及时治疗的患者视力提高幅度更大(6.4个字母[SD,8.1个字母]对1.2个字母[SD,5.3个字母;P = 0.04]),视力达到6/12或更好的比例更高(30%对8%;P = 0.01),12个月时光学相干断层扫描(OCT)测量的中心子场厚度减少幅度更大(135μm[SD,154μm]对87.8μm[SD,129μm];P = 0.04)。活动性疾病检测与再治疗之间的延迟时间越长,视力结局越差(每天下降0.02个字母;P = 0.03;R = 0.29)。

结论

虽然已确定需要足够数量的注射才能获得良好结局,但对活动性疾病进行及时再治疗也很重要。应向患者强调这一点,以确保在真实世界临床环境中获得最佳结局。

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