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Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial.玻璃体内注射阿柏西普 8mg 治疗新生血管性年龄相关性黄斑变性(PULSAR):一项随机、双盲、非劣效性、3 期临床试验的 48 周结果。
Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.
2
Real-world study to evaluate the efficacy and safety of intravitreal brolucizumab for refractory neovascular age-related macular degeneration.真实世界研究评估玻璃体腔内注射 brolucizumab 治疗难治性新生血管性年龄相关性黄斑变性的疗效和安全性。
Sci Rep. 2023 Jul 14;13(1):11400. doi: 10.1038/s41598-023-38173-y.
3
Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration.抗 VEGF 药物治疗新生血管性年龄相关性黄斑变性后眼内炎症的检测与处理
Ophthalmol Retina. 2023 Oct;7(10):879-891. doi: 10.1016/j.oret.2023.06.009. Epub 2023 Jun 19.
4
Real-Life Experience and Predictors of Visual Outcomes with Intravitreal Brolucizumab Switch for Treatment of Neovascular Age-Related Macular Degeneration.玻璃体内注射布罗利珠单抗转换治疗新生血管性年龄相关性黄斑变性的真实临床经验和预测结果。
Ophthalmologica. 2023;246(2):158-168. doi: 10.1159/000530544. Epub 2023 Apr 11.
5
High-Dose Aflibercept for Neovascular AMD and DME in Suboptimal Responders to Standard-Dose Aflibercept.高剂量阿柏西普用于对标准剂量阿柏西普反应欠佳的新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿患者
J Vitreoretin Dis. 2023 Feb 15;7(2):116-124. doi: 10.1177/24741264221150345. eCollection 2023 Mar-Apr.
6
Age-related macular degeneration.年龄相关性黄斑变性
Lancet. 2023 Apr 29;401(10386):1459-1472. doi: 10.1016/S0140-6736(22)02609-5. Epub 2023 Mar 27.
7
Factors Linked to Injection Interval Extension in Eyes with Wet Age-Related Macular Degeneration Switched to Brolucizumab.与湿性年龄相关性黄斑变性转为康柏西普治疗后注射间隔延长相关的因素。
Ophthalmology. 2023 Aug;130(8):795-803. doi: 10.1016/j.ophtha.2023.03.017. Epub 2023 Mar 27.
8
Switching to brolucizumab from aflibercept in age-related macular degeneration with type 1 macular neovascularization and polypoidal choroidal vasculopathy: an 18-month follow-up study.在伴有1型黄斑新生血管和息肉样脉络膜血管病变的年龄相关性黄斑变性患者中从阿柏西普转换为布罗卢izumab:一项18个月的随访研究。
Graefes Arch Clin Exp Ophthalmol. 2023 Feb;261(2):345-352. doi: 10.1007/s00417-022-05793-5. Epub 2022 Aug 10.
9
First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration.玻璃体内注射布罗珠单抗治疗难治性新生血管性年龄相关性黄斑变性的第一年真实生活经验
Front Pharmacol. 2022 May 30;13:860784. doi: 10.3389/fphar.2022.860784. eCollection 2022.
10
Comparison of agents using higher dose anti-VEGF therapy for treatment-resistant neovascular age-related macular degeneration.比较使用高剂量抗血管内皮生长因子药物治疗抵抗性新生血管性年龄相关性黄斑变性。
Graefes Arch Clin Exp Ophthalmol. 2022 Jul;260(7):2239-2247. doi: 10.1007/s00417-021-05547-9. Epub 2022 Jan 29.

高剂量布罗鲁单抗治疗对标准剂量布罗鲁单抗耐药的难治性新生血管性年龄相关性黄斑变性

High-Dose Brolucizumab for Refractory Neovascular Age-Related Macular Degeneration Resistant to Standard-Dose Brolucizumab.

作者信息

Kim Jinsoo, Park Min Seon, Cho Bum-Joo, Kwon Soonil

机构信息

Department of Ophthalmology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang, Gyeonggi, 14068, Republic of Korea.

出版信息

Ophthalmol Ther. 2024 Oct;13(10):2789-2797. doi: 10.1007/s40123-024-01022-w. Epub 2024 Aug 30.

DOI:10.1007/s40123-024-01022-w
PMID:39214946
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11408427/
Abstract

INTRODUCTION

The aim of this study was to evaluate the efficacy and safety of escalating the dosage of intravitreal brolucizumab in patients with refractory neovascular age-related macular degeneration (AMD).

METHODS

This retrospective study included 17 eyes of 17 patients with refractory AMD treated with high-dose brolucizumab (12 mg/0.1 ml) for over 12 months. Patients initially received at least one anti-vascular endothelial growth factor (anti-VEGF) agent and were switched to standard-dose brolucizumab (6 mg/0.05 ml). Those who showed a suboptimal response to standard-dose treatment had their dosage of brolucizumab escalated.

RESULTS

Visual acuity was maintained from 68.3 ± 3.4 letters to 70.7 ± 3.2 letters after 12 months of high-dose treatment (P = 0.128). Central subfield thickness was 343.7 ± 17.0 μm before high-dose treatment and 316.7 ± 18.5 μm at 12 months (P = 0.083). The proportions of patients with subretinal fluid and serous pigment epithelial detachment significantly decreased from 82.4% to 41.2% and from 52.9% to 17.6%, respectively, after high-dose treatment (P = 0.039 and P = 0.031, respectively). The treatment interval extended from 7.2 ± 2.4 weeks to 10.2 ± 2.2 weeks after switching to standard-dose brolucizumab (P < 0.001) and was maintained at 13.5 ± 2.8 weeks after increasing the dose (P = 0.154). No severe ocular adverse events were observed.

CONCLUSIONS

High-dose brolucizumab was effective in patients who did not respond to standard-dose brolucizumab after switching from previous anti-VEGF agents. Increasing the dosage could offer sustained disease control and reduce the treatment burden for patients with refractory AMD.

摘要

引言

本研究旨在评估递增玻璃体内注射布罗芦izumab剂量对难治性新生血管性年龄相关性黄斑变性(AMD)患者的疗效和安全性。

方法

本回顾性研究纳入了17例难治性AMD患者的17只眼,这些患者接受高剂量布罗芦izumab(12毫克/0.1毫升)治疗超过12个月。患者最初至少接受过一种抗血管内皮生长因子(抗VEGF)药物治疗,之后改用标准剂量布罗芦izumab(6毫克/0.05毫升)。对标准剂量治疗反应欠佳的患者,其布罗芦izumab剂量递增。

结果

高剂量治疗12个月后,视力从68.3±3.4个字母维持到70.7±3.2个字母(P = 0.128)。高剂量治疗前中心子野厚度为343.7±17.0微米,12个月时为316.7±18.5微米(P = 0.083)。高剂量治疗后,视网膜下液和浆液性色素上皮脱离患者的比例分别从82.4%显著降至41.2%,从52.9%降至17.6%(P分别为0.039和0.031)。改用标准剂量布罗芦izumab后,治疗间隔从7.2±2.4周延长至10.2±2.2周(P < 0.001),剂量增加后维持在13.5±2.8周(P = 0.154)。未观察到严重眼部不良事件。

结论

高剂量布罗芦izumab对从先前抗VEGF药物转换后对标准剂量布罗芦izumab无反应的患者有效。增加剂量可为难治性AMD患者提供持续的疾病控制并减轻治疗负担。