CompletedPhase 3

RESCUE and REVERSE Long-term Follow-up

United States, France, Germany62 participantsStarted 2018-01-09

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

Who can participate

Age range15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Ocular Adverse Events (AEs)

Timeframe: from year 2 to year 5 post treatment

Trial details

NCT IDNCT03406104

SponsorGenSight Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-04

Results submitted2023-09-26

View on ClinicalTrials.gov More Leber Hereditary Optic Neuropathy trials