The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa via Subretinal Injection of The 3rd Generation of Recombinant Simian Immunodeficiency Virus (SIVagm) Vector Expressing Human Pigment Epithelium-Derived Factor (hPEDF) Gene
- Conditions
- Retinitis Pigmentosa
- Registration Number
- JPRN-UMIN000010260
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Human immunodeficiency virus (HIV) antibody-positive subjects 2. Blindness 3. Subjects with a macular complication of retinitis pigmentosa (eg: macular degeneration,macular edema, etc.) 4. A past history of glaucoma 5. Subjects with retinal or subretinal disorders 6. Subjected with severe allergy or its history. 7. Subjects receiving chronic hemodialysis therapy 8. Subjects who have severe heart dysfunction or faiure 9. Subjects who have hepatic dysfunction or cirrhosis 10. Subject who have active inflammatory diseases 11. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment 12. Subjects with hematopoietic disorders 13. Alcoholism and/or drug dependence 14. Female subjects with pregnant or doubt of pregnancy 15. Subjects who are diagnosed with cancer or are suspected to cancer 16. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment 17. Subjects who disapprove of birth control during at least 12 months after the vector administration 18. Subjects who take the antiviral drug at the registration 19. Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Physical examination 2. Blood and urine analyses 3. Vital signs 4. Ophthalmic examination 5. Adverse events 6. Viral shedding
- Secondary Outcome Measures
Name Time Method 1. Best corrected visual acuity 2. Visual field measurement testing 3. VFQ25