BS01 in Patients With Retinitis Pigmentosa

NCT04278131 · tracked via the Priya Life Science USA tracker

Sponsor

Bionic Sight LLC

Phase

Phase 1/2

Started

2020-02-06

Last updated

2026-01-23

Condition(s) studied

Retinitis Pigmentosa

Investigational drug(s) / intervention(s)

BS01

BS01: Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)

Study summary

A Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAG-ChronosFP) in Patients with Retinitis Pigmentosa

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Confirmed diagnosis of retinitis pigmentosa * At least one eye with vision no better than 20/160 visual acuity on the EDTRS scale or, for patients with peripheral vision loss, a visual field no greater than 30°. Exclusion Criteria: * Prior receipt of any AAV gene therapy product * Large amplitude nystagmus

Primary outcome measure(s)

Primary Outcome Measure — 12 months
Number of subjects with adverse events, changes in hematology/chemistry

Trial sites (1)

Facility	City	Region	Status
New Jersey Retina	Teaneck	New Jersey	Recruiting

More Bionic Sight LLC trials in the USA

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD Recruiting

Other trials for the same condition

Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration Recruiting

Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study Active, not recruiting

A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa Active, not recruiting

Natural History of PRPF31 Mutation-Associated Retinal Dystrophy Active, not recruiting

A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04278131 on ClinicalTrials.gov ↗ ← All trials in the USA