Retrospective Analysis of Imaging and Clinical Features From Patients Treated With Brolucizumab in Post-marketing Setting With Reports of Intraocular Inflammation and/or Retinal Vascular Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Number of eye cases by occlusion type by reading center eye case classification
研究概览
简要总结
This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.
详细描述
The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.
Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists [TFUs]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.
All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre
排除标准
- 未提供
结局指标
主要结局
Number of eye cases by occlusion type by reading center eye case classification
时间窗: throughout the study period of 5 months
Occlusion type by reading center eye case classification is provided: * Central * Branch * Peripheral
Number of eye cases by grading variables per imaging modality by reading center eye case classification
时间窗: throughout the study period of 5 months
Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided
Number of eye cases by anatomical location and sub-location
时间窗: throughout the study period of 5 months
Number of eye cases by anatomical location and sub-location is provided: * Retina: Vascular and general) * Vitreous * Choroid * Optic nerve
Eye case classification based on imaging data
时间窗: throughout the study period of 5 months
Eye case classification based on imaging data is provided: * IOI: intraocular inflammation (posterior segment only) * RV: Retinal vasculitis * RO: Retinal vascular occlusion * Not assessable: image quality concerns prevented grading * None: no imaging features of IOI, RV, or RO
Number of eye cases by Anatomical location in relation to macula
时间窗: throughout the study period of 5 months
Number of eye cases by Anatomical location in relation to macula is provided:
Number of eye cases by extent of involvement of the retinal arterial and vein occlusion
时间窗: throughout the study period of 5 months
Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided
次要结局
未报告次要终点