Actively Recruiting
Phase 12 Safety and Effectiveness Study of BS01 Gene Therapy for Retinitis Pigmentosa
Led by Bionic Sight LLC · Updated on 2026-01-23
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BS01, a gene therapy using a recombinant adeno-associated virus vector that expresses ChronosFP, in patients with retinitis pigmentosa. This Phase 12 trial aims to explore how this investigational treatment may affect vision in people affected by this condition. Participants receive BS01 in different dose groups called cohorts, with each cohort receiving a specific dose level. The study includes multiple cohorts labeled Cohort 1 through Cohort 6, and some participants may receive treatment in the opposite eye. BS01 is a non-replicating viral vector designed to deliver an enhanced light-sensitive gene. During the study, participants will undergo evaluations over 12 months to measure the primary and secondary outcomes related to safety and vision changes. Assessments may include visual acuity tests and visual field measurements. The study follows participants to monitor the effects and any safety concerns associated with the gene therapy.
CONDITIONS
Brief Title
BS01 in Patients With Retinitis Pigmentosa
Research Team
M
Minako Koga
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