Status:
COMPLETED
A Study to Assess Choroideremia (CHM) Health Outcomes
Lead Sponsor:
Biogen
Conditions:
Choroideremia
Eligibility:
MALE
Brief Summary
The primary objectives of this study are to describe disease progression and severity by age in participants with CHM, to assess health-related quality-of-life, resource utilization and work productiv...
Eligibility Criteria
Inclusion
- Key
- Physician Participants
- At least 60% of time spent in direct participant care.
- Board-certified or eligible with a Specialty in Ophthalmology, such as Retinal Specialist, IRD Specialist, Retinal Surgeon.
- Patient Participants
- CHM diagnosis confirmed via genetic testing.
- Include any minimal disease severity requirement.
- Participant has at least one record of visual acuity measurement in the past 24 months, OR has be assigned by the treating clinician as having severe VA impairment of blind/legally blind by using one of the following methods: finger counting, hand movement, light perception / no light perception.
- Key
Exclusion
- Physician Participants
- a. Participating physicians must not be affiliated with an approved management organization.
- Patient Participants
- a. Participants who received gene therapy or any other investigational treatment and participants who do not agree to informed consent.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04750785
Start Date
December 15 2020
End Date
September 27 2021
Last Update
October 14 2021
Active Locations (8)
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1
Research Site
Los Angeles, California, United States, 90095
2
Research Site
San Francisco, California, United States, 94158
3
Research Site
Coral Gables, Florida, United States, 33146
4
Research Site
Gainesville, Florida, United States, 32607