A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of UshStat® in Patients With Usher Syndrome Type 1B
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/18/2018 |
| Start Date: | September 12, 2013 |
| End Date: | January 15, 2036 |
An Open-Label Study to Determine the Long-Term Safety, Tolerability and Biological Activity of UshStat® in Patients With Usher Syndrome Type 1B
Primary Objective:
To evaluate the long-term safety and tolerability of UshStat® in patients with Usher syndrome
type 1B
Secondary Objective:
To assess long-term safety and biological activity of UshStat®
To evaluate the long-term safety and tolerability of UshStat® in patients with Usher syndrome
type 1B
Secondary Objective:
To assess long-term safety and biological activity of UshStat®
Inclusion Criteria:
- Provide signed and dated written informed consent (and if appropriate assent) and any
locally required authorization eg, Health Insurance Portability and Accountability Act
(HIPAA).
- Must have been enrolled in Protocol TDU13600
- Must have received a subretinal injection of UshStat®
Exclusion Criteria:
- Did not receive UshStat® as part of the TDU13600 protocol
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials