EUCTR2016-003856-59-GBActive, not recruitingPhase 1
ong-term follow-up study of participants following an open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/8-hCARp.hCNGB3) for gene therapy of adults and children with achromatopsia owing to defects in CNGB3
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- MeiraGTX UK II Ltd
- Enrollment
- 27
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Are able to give informed consent or assent, with or without the guidance of their parent/guardian where appropriate
- •- Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving intraocular administration of AAV2/8-hCARp.hCNGB3
- •- Are willing to adhere to the protocol and long-term follow-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
Investigators
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