At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
GS010 +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REVERSE Phase III Clinical Trials (RESTORE)
In Brief
A Phase 3 clinical trial evaluating GS010 and Sham Intravitreal Injection for Leber Hereditary Optic Neuropathy. Completed, enrolled 62 participants across 7 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeber Hereditary Optic Neuropathy
CountriesFrance, Germany, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedJan 2018
Primary CompletionJul 2022
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartJan 9, 2018
Primary CompletionJul 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.4 years ago
Interventions
GS010genetic
Lenadogene nolparvovec Intravitreal ocular unilateral Injection
Sham Intravitreal Injectionother
Lenadogene nolparvovec Intravitreal ocular unilateral Injection