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Clinical Trials in the USA / NCT04278131
Recruiting Phase 1/2

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
No
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)

FacilityCityRegionStatus
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

A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) Recruiting
Prospective Natural History Study of Retinitis Pigmentosa Active, not recruiting
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION) Active, not recruiting
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa Active, not recruiting
Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP) Active, not 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