Status:
COMPLETED
RESCUE and REVERSE Long-term Follow-up
Lead Sponsor:
GenSight Biologics
Conditions:
Leber Hereditary Optic Neuropathy
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutat...
Detailed Description
Seven investigational centers from the RESCUE and REVERSE studies also participated in the RESTORE study, located in the European union and in the USA. Primary objectives: to assess the long term saf...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject was treated with GS010 IVT injection in either of the RESCUE or REVERSE Phase III clinical studies
- Subject of legal consent age has provided informed consent; subjects that are not of legal consent age have undergone their country-approved clinical trial enrollment consent process
- Exclusion Criteria
- Subject is unwilling or unable to comply with the protocol requirements
- Subject has any medical or psychological condition that, in the opinion of the Investigator, may compromise his or her safe participation in the study
- Subject is taking or intending to take idebenone during the long-term follow-up study period
Exclusion
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03406104
Start Date
January 9 2018
End Date
July 4 2022
Last Update
September 9 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Doheny Eye Center UCLA
Pasadena, California, United States, 91105
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
4
CHNO Les Quinze Vingts
Paris, France, 75012