A Retrospective Cohort Analysis of the Natural Disease Progression of Patients With Choroideremia in Real-World Clinical Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Choroideremia
- Sponsor
- Biogen
- Enrollment
- 1178
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with Progression of BCVA Over Time After the Baseline BCVA
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Outcomes
Primary Outcomes
Percentage of Participants with Progression of BCVA Over Time After the Baseline BCVA
Time Frame: Up to 6 years
Percentage of Participants with Progression of Best Corrected Visual Acuity (BCVA) in Relation to Age
Time Frame: Up to 6 years
Secondary Outcomes
- 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)