Status:
RECRUITING
Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
Lead Sponsor:
Frontera Therapeutics
Conditions:
X-Linked Retinitis Pigmentosa (XLRP)
Eligibility:
MALE
8-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regu...
Eligibility Criteria
Inclusion
- Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;
- Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;
- Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;
Exclusion
- Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06492850
Start Date
April 1 2024
End Date
February 1 2026
Last Update
July 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100142