Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | BSO1 Cohort 1 dose |
|
| Cohort 2 | Experimental | BS01 Cohort 2 dose |
|
| Cohort 3 | Experimental | BS01 Cohort 3 dose |
|
| Cohort 4 | Experimental | BS01 Cohort4 dose |
|
| Cohort 5 | Experimental | BS01 Cohort4 dose |
|
| Cohort 6 | Experimental | Treat opposite eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BS01 | Drug | Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Number of subjects with adverse events, changes in hematology/chemistry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures | Changes in light detection (threshold to detect) Changes in motion detection Changes in shape/object/letter detection Changes in performance on maze navigation task | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minako Koga | Contact | mkoga@kmphc.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheila Nirenberg, PhD | Bionic Sight LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Retina | Recruiting | Teaneck | New Jersey | 07666 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |