Evaluation of long-term safety and efficacy after neuroprotective gene therapy with SIV-hPEDF for retinitis pigmentosa
Not Applicable
- Conditions
- Retinitis Pigmentosa
- Registration Number
- JPRN-UMIN000049825
- Lead Sponsor
- Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Patients whom the investigator determines are not appropriate as research subjects
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in visual acuity (logMAR equivalent)
- Secondary Outcome Measures
Name Time Method 1. Rate of change in mean retinal sensitivity at the 12 center points in HFA10-2 static perimetry tests 2. Rate of change in mean retinal sensitivity at the 4 center points in HFA10-2 static perimetry tests 3. Percentage of serious adverse events for which a causal relationship with DVC1-0401 cannot be ruled out