BS01 in Patients With Retinitis Pigmentosa

Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04278131

Enrollment

Registered

2020-02-20

Start date

2020-02-06

Completion date

2029-12-30

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Brief 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

Interventions

DRUGBS01

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Secondary Outcome Measures	12 months	Changes in light detection (threshold to detect) Changes in motion detection Changes in shape/object/letter detection Changes in performance on maze navigation task

Countries

United States

Contacts

CONTACTMinako Koga

mkoga@kmphc.com

STUDY_DIRECTORSheila Nirenberg, PhD

Bionic Sight LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026