A Retrospective Cohort Analysis of the Natural Disease Progression of Patients With Choroideremia in Real-World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,178
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Progression of BCVA Over Time After the Baseline BCVA
研究概览
简要总结
The primary objective of this study is to quantify disease progression measured by best corrected visual acuity (BCVA) in the real-world setting among Choroideremia (CHM) participants. The secondary objectives are to describe demographic and baseline clinical characteristics among CHM participants and to match CHM participants in the Intelligent Research in Sight (IRIS®) Registry to Biogen's investigator sponsored trial (IST) study population using propensity score matching.
详细描述
This study is a retrospective cohort study of CHM eyes and participants which will include all eligible participants and eyes with the first documented diagnosis of CHM from July 1st, 2013 to December 31st, 2019 that meet the study criteria. This study will be conducted using data from American Academy of Ophthalmology's (AAO) IRIS® Registry which captures CHM participant's demographics, clinical characteristics and clinical outcomes from 2013.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1: All CHM Participants
- •Participants with a documented diagnosis of CHM identified by the presence of International Classification of Diseases (ICD)-9/10 or SNOMED coding:
- •ICD-9: 363.55
- •ICD-10: H31.2
- •SNOMED-CT: 75241009
- •Cohort 2: Trial-Matched CHM Participants
- •Male participants with a documented diagnosis of CHM identified by the presence of ICD-9/10 or SNOMED coding:
- •ICD-9: 363.55
- •ICD-10: H31.21
- •SNOMED-CT: 75241009
排除标准
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Percentage of Participants with Progression of BCVA Over Time After the Baseline BCVA
时间窗: Up to 6 years
Percentage of Participants with Progression of Best Corrected Visual Acuity (BCVA) in Relation to Age
时间窗: Up to 6 years
次要结局
- Percentage of Participants with Demographics Described at Baseline(Up to 6 years)
- Matching Participants with CHM in the IRIS® Registry to Biogen's IST Study Population Using Propensity Score (PS) Matching(Up to 6 years)