Recruiting
Phase 1
Phase 2

BS01

Sponsor:

Bionic Sight LLC

Code:

NCT04278131

Conditions

Retinitis Pigmentosa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BS01

Study Details

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

Conditions

Retinitis Pigmentosa

Study ID

NCT04278131

Start date

Feb 6, 2020

Status verified date

Jan, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

BSO1 Cohort 1 dose

experimental: Cohort 2

BS01 Cohort 2 dose

experimental: Cohort 3

BS01 Cohort 3 dose

experimental: Cohort 4

BS01 Cohort4 dose

experimental: Cohort 5

BS01 Cohort4 dose

experimental: Cohort 6

Treat opposite eye

Interventions

BS01

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

Primary outcome measure

  • Primary Outcome Measure [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Minako Koga

mkoga@kmphc.com

Locations

New Jersey Retina

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Lauryn Onkendi

(201)837-7300lonkendi@njretina.com

Principal Investigator:

Paul Hahn, MD

More Information

Sponsor

Bionic Sight LLC

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Bionic Sight LLC on 2026-01-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.