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临床试验/NCT05220085
NCT05220085Unknown不适用

Real-life Beovu Experience at UZ Leuven for the Treatment of Exudative Neovascular Age-related Macular Degeneration

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
17
试验地点
1
主要终点
anatomical efficacy of treatment with brolucizumab

研究概览

简要总结

Reporting early real-world clinical data of consecutive patients on the use of Beovu® (brolucizumab) intravitreal injections in patients with neovascular age-related macular degeneration.

详细描述

Brolucizumab (Beovu, Novartis, Basel, Switzerland) is the newest anti-vascular endothelial growth factor (anti-VEGF) drug. It received FDA approval for the treatment of neovascular age-related macular degeneration (nAMD) in October 2019 followed by EMA approval in February 2020. Brolucizumab received marketing approval based on the two pivotal phase 3 clinical trials - HAWK and HARRIER - with a q8/q12 week dosing regimen. Potential benefits of brolucizumab are assumed to be related to its low molecular weight with subsequent better tissue penetration as well as higher molar concentration. This could improve the treatment durability and lower the burden for patients and caregivers when dealing with repetitive intravitreal treatments and monitoring visits over a long period of time in a chronic disease. However, safety signals have been reported in both RCTs and post-marketing reports, which included the occurrence of intraocular inflammation (IOI) and retinal vasculitis with or without occlusion.

In this study we want to share our early results and experience with Bolucizumab in UZ Leuven. By retrospective analysis of a cohort of 17 patients treated with Brolucizumab, we evaluate the efficacy of the drug as well as the occurrence of adverse-events, especially intra-ocular inflammation and vasculitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of neovascular age-related macular degeneration
  • Partial response on current anti-VEGF treatment or unability to prolong the treatment interval beyond 6 or 8 weeks

排除标准

  • Any form of previous intraocular inflammation
  • Any form of previous inflammatory reaction after anti-VEGF treatment
  • Functionally monophthalmic patients
  • Any sign of active intraocular inflammation

结局指标

主要结局

anatomical efficacy of treatment with brolucizumab

时间窗: dec 2020- nov 2021

central retinal thickness

functional efficacy of treatment with brolucizumab

时间窗: dec 2020- nov 2021

best corrected visual acuity

次要结局

  • Safety of treatment with brolucizumab(dec 2020- nov 2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JulieJacob

prof.dr.Julie Jacob

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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