Trials / Completed
CompletedNCT04795206
Natural Disease Progression in Participants With Choroideremia
A Retrospective Cohort Analysis of the Natural Disease Progression of Patients With Choroideremia in Real-World Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,178 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2020-08-26
- Primary completion
- 2021-05-07
- Completion
- 2021-08-10
- First posted
- 2021-03-12
- Last updated
- 2021-09-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04795206. Inclusion in this directory is not an endorsement.