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Long-term Follow-up Study of Participants Following an Open Label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children With Retinal Dystrophy Owing to Defects in RPE65 (LCA2)
This study is a longer-term follow-up study for patients who have been administered AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in RPE65.
The follow up study is designed to collect data on longer-term safety and efficacy of AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial.
Age
3 - 100 years
Sex
ALL
Healthy Volunteers
No
Kellogg Eye Center, University of Michigan Health
Ann Arbor, Michigan, United States
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
Start Date
November 1, 2016
Primary Completion Date
July 1, 2023
Completion Date
July 1, 2023
Last Updated
April 11, 2024
15
ACTUAL participants
AAV OPTIRPE65
BIOLOGICAL
Lead Sponsor
MeiraGTx UK II Ltd
NCT07228793
NCT06177639
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05147701