Actively Recruiting
Phase 1/2 Safety and Efficacy Trial of BS01, a Gene Therapy Using Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa
Led by Bionic Sight LLC · Updated on 2026-01-23
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
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 1/2 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of retinitis pigmentosa
- At least one eye with vision no better than 20/160 visual acuity on the EDTRS scale or a visual field no greater than 30 degrees
You will not qualify if you...
- Prior receipt of any adeno-associated virus (AAV) gene therapy product
- Large amplitude nystagmus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive BS01 gene therapy treatment for retinitis pigmentosa.
1 baseline visit and multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
New Jersey Retina
Teaneck, New Jersey, United States, 07666
Actively Recruiting
Research Team
M
Minako Koga
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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