Status:
COMPLETED
REALITY LHON Registry
Lead Sponsor:
GenSight Biologics
Conditions:
Leber Hereditary Optic Neuropathy
Eligibility:
All Genders
Brief Summary
This study is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administr...
Detailed Description
The purpose of this study is to understand the evolution of visual functional and structural changes and other associated symptoms in patients with LHON. The relation between genetic, lifestyle and/or...
Eligibility Criteria
Inclusion
- Subjects who have a confirmed and genotyped diagnosis of LHON;
- Subjects with visual function outcomes data including at least 2 visual function assessments between 1 year and 3 years (+/- 4 weeks) after vision loss;
- Subjects who are willing and able to provide written informed consent if required as per local regulations;
- For LHON subjects under the age of 18 years, permission from a legal guardian to participate in the study;
Exclusion
- Subjects who received any investigational drug, or participated in any LHON-related interventional clinical trial during the observational period;
- Subjects without medical charts data available.
Key Trial Info
Start Date :
January 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03295071
Start Date
January 3 2018
End Date
July 1 2020
Last Update
February 8 2021
Active Locations (11)
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1
Doheny Eye Center UCLA Pasadena
Pasadena, California, United States, 91105
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
4
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107