RESCUE and REVERSE Long-term Follow-up

Completed · Phase 3 · Has a placebo group

Conditions studied: Leber Hereditary Optic Neuropathy

In brief

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 mutation and who were treated in the Rescue or Reverse studies.

Key facts

Study ID

NCT03406104

Run by

GenSight Biologics

People needed

62

Starts

2018-01-09

Expected to finish

2022-07-04

Last updated by the study team

2026-03-02

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Doheny Eye Center UCLA — Pasadena, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Wills Eye Institute — Philadelphia, Pennsylvania, United States
• CHNO Les Quinze Vingts — Paris, France
• LMU Klinikum der Universität München / Friedrich-Baur-Institut — Munich, Germany
• Ospedale Bellaria — Bologna, Italy
• Moorfields Eye Hospital — London, Greater London, United Kingdom

Full record on ClinicalTrials.gov

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