BS01 in Patients With Retinitis Pigmentosa

Bionic Sight

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Retinitis Pigmentosa

Treatments: Drug: BS01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278131

BS01-RP-001

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of retinitis pigmentosa
• Bare light perception in at least one eye

Exclusion criteria

• Prior receipt of any AAV gene therapy product
• Large amplitude nystagmus

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Cohort 1

Experimental group

Description:

BSO1 Cohort 1 dose

Treatment:

Drug: BS01

Cohort 2

Experimental group

Description:

BS01 Cohort 2 dose

Treatment:

Drug: BS01

Cohort 3

Experimental group

Description:

BS01 Cohort 3 dose

Treatment:

Drug: BS01

Cohort 4

Experimental group

Description:

BS01 Cohort4 dose

Treatment:

Drug: BS01

Cohort 5

Experimental group

Description:

BS01 Cohort4 dose

Treatment:

Drug: BS01

Cohort 6

Experimental group

Description:

Treat opposite eye

Treatment:

Drug: BS01