Real-life Beovu Experience at UZ Leuven for the Treatment of Exudative Neovascular Age-related Macular Degeneration
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
- 否
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
JulieJacob
prof.dr.Julie Jacob
Universitaire Ziekenhuizen KU Leuven
