Status:
COMPLETED
Natural History of the Progression of Choroideremia Study
Lead Sponsor:
NightstaRx Ltd, a Biogen Company
Conditions:
Choroideremia
Eligibility:
MALE
18+ years
Brief Summary
The objective of this natural history study is to gain a better understanding of the progression of choroideremia (CHM) and add to the knowledge base for this rare disease.
Detailed Description
This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Key
- Are willing and able to provide informed consent for participation in the study.
- Have a clinical phenotype and confirmed genetic diagnosis of CHM.
- Have active disease clinically visible within the macular region.
- Are willing and able to undergo ophthalmic examinations once every 4 months for up to 20 months.
- Have a BCVA better than or equal to 6/60 (20/200; decimal 0.1; LogMAR 1.0; 34-38 ETDRS letters) in at least one eye.
- Key
Exclusion
- Have a history of amblyopia in the eligible eye.
- Have any other significant ocular or non-ocular disease/disorder in the eligible eye which, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or influence the subject's ability to participate in the study.
- Have participated in an interventional research study in the past 6 months.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 30 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT03359551
Start Date
June 30 2015
End Date
October 1 2020
Last Update
February 10 2023
Active Locations (20)
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1
Research Site
Los Angeles, California, United States, 90095
2
Research Site
Miami, Florida, United States, 33136
3
Research Site
Baltimore, Maryland, United States, 21287
4
Research Site
New York, New York, United States, 10032