Natural Disease Progression in Participants With Choroideremia

NCT ID: NCT04795206

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-26

Study Completion Date

2021-08-10

Brief Summary

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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 (IRISĀ®) Registry to Biogen's investigator sponsored trial (IST) study population using propensity score matching.

Detailed Description

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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) IRISĀ® Registry which captures CHM participant's demographics, clinical characteristics and clinical outcomes from 2013.

Conditions

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Choroideremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1: Main Cohort

All eligible participants with CHM in IRIS Registry will be included.

No Intervention

Intervention Type OTHER

Administered as specified in the treatment arm.

Cohort 2: Trial-Matched Cohort

Only male participants with CHM from Cohort 1 to match Biogen's IST study population using propensity score matching will be included.

No Intervention

Intervention Type OTHER

Administered as specified in the treatment arm.

Interventions

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No Intervention

Administered as specified in the treatment arm.

Intervention Type OTHER

Eligibility Criteria

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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:

1. ICD-9: 363.55
2. ICD-10: H31.2
3. 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:

1. ICD-9: 363.55
2. ICD-10: H31.21
3. SNOMED-CT: 75241009

Exclusion Criteria

* N/A
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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US-CHM-11761

Identifier Type: -

Identifier Source: org_study_id

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