Retinitis Pigmentosa Clinical Trial
Official title:
Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa
| Verified date | May 2023 |
| Source | Bionic Sight LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Non-randomized, open label, Phase 1/2 dose escalation study of BS01, a non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP).
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | December 30, 2029 |
| Est. primary completion date | December 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of retinitis pigmentosa - Bare light perception in at least one eye Exclusion Criteria: - Prior receipt of any AAV gene therapy product - Large amplitude nystagmus |
| Country | Name | City | State |
|---|---|---|---|
| United States | OCLI | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Bionic Sight LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Outcome Measure | Number of subjects with adverse events, changes in hematology/chemistry | 12 months | |
| Secondary | Secondary Outcome Measures | Changes in light detection by Diagnosys visual function testing Changes in shape and motion detection by Diagnosys visual function testing |
12 months |
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