BS01 in Patients With Retinitis Pigmentosa

Phase 1

Active, not recruiting

• Conditions: Retinitis Pigmentosa
• Interventions: Drug: BS01

• Registration Number: NCT04278131
• Lead Sponsor: Bionic Sight LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-06
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 4	BS01	BS01 Cohort4 dose
Cohort 1	BS01	BSO1 Cohort 1 dose
Cohort 6	BS01	Treat opposite eye
Cohort 2	BS01	BS01 Cohort 2 dose
Cohort 5	BS01	BS01 Cohort4 dose
Cohort 3	BS01	BS01 Cohort 3 dose

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New Jersey Retina; 🇺🇸 Teaneck, New Jersey, United States