A US Real-World Evidence Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155,413
- 试验地点
- 1
- 主要终点
- Incidence of suspected endophthalmitis by ophthalmic delivery mechanism
研究概览
简要总结
Specific study objectives include:
- To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).
- To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.
Secondary objectives
• To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.
详细描述
This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism
时间窗: End of Study, Approximately 8 Years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes. Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Frequency of aflibercept injections by ophthalmic delivery mechanism
时间窗: End of Study, Approximately 8 Years
Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Frequency of patients receiving aflibercept injections
时间窗: End of Study, Approximately 8 Years
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism
时间窗: End of Study, Approximately 8 Years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes. Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Incidence of suspected endophthalmitis
时间窗: End of Study, Approximately 8 Years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.
Incidence of Intraocular inflammation (IOI)
时间窗: End of Study, Approximately 8 Years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.
次要结局
未报告次要终点