RESCUE and REVERSE Long-term Follow-up

Description

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.

Study Start Date

January, 09 2018

Estimated Completion Date

August 2022

Interventions

  • Other: Sham Intravitreal Injection
  • Genetic: GS010

Study ID

GenSight Biologics -- GS-LHON-CLIN-06

Status

Recruiting

Trial ID

NCT03406104

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

74

Sponsor

GenSight Biologics

Inclusion Criteria Subjects must meet all the following criteria at Inclusion period to be eligible for inclusion.
  • 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 Non-Inclusion Criteria Subjects meeting any of the following criteria at Inclusion period will be excluded from eligibility.
  • 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
  • Gender

    All

    Ages

    15 Years and older

    Accepts Healthy Volunteers

    Not Listed

    Study Locations and Contact Information (3)

    Study Location Distance Name Phone Email
    Wills Eye Institute - Philadelphia, Pennsylvania 133.3 miles Maria Massini None mmassini@willseye.org
    Emory University Hospital - Atlanta, Georgia 795.6 miles Lindy Dubois None ldubois@emory.edu
    Doheny Eye Center UCLA - Pasadena, California 2,482.6 miles Rosio Mendoza None r.mendoza@jsei.ucla.edu

    ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.