Study detail
RecruitingPhase 1
Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa
Bionic Sight LLC
Summary
A Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAG-ChronosFP) in Patients with Retinitis Pigmentosa
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: * Confirmed diagnosis of retinitis pigmentosa * At least one eye with vision no better than 20/160 visual acuity on the EDTRS scale or, for patients with peripheral vision loss, a visual field no greater than 30°. Exclusion Criteria: * Prior receipt of any AAV gene therapy product * Large amplitude nystagmus
Interventions
- DrugBS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Location
- New Jersey RetinaTeaneck, New Jersey