Status:
COMPLETED
Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)
Lead Sponsor:
MeiraGTx UK II Ltd
Collaborating Sponsors:
Syne Qua Non Limited
Bionical Emas
Conditions:
X-Linked Retinitis Pigmentosa
Eligibility:
MALE
5+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase 1 of the study is a dose escalation of the subretinal administration of AAV5-hRKp.RPGR vector to assess the safety of this vector in participants with XLRP caused by mutations in RPGR. Participa...
Detailed Description
This is an open-label phase 1/2 dose-escalation and cohort expansion trial to determine the safety and efficacy of subretinal administration of AAV5-hRKp.RPGR vector in participants with XLRP caused b...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- Males aged 5 years or older
- Have X-linked retinitis pigmentosa confirmed by a retinal specialist (CI or PI)
- Key exclusion Criteria:
- • Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months
Exclusion
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03252847
Start Date
July 31 2017
End Date
November 18 2021
Last Update
January 8 2025
Active Locations (5)
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1
Massachusetts Eye and Ear Institute
Boston, Massachusetts, United States, 02114
2
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
3
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
4
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF