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RecruitingNCT04278131Updated Jan 23, 2026

BS01 in Patients With Retinitis Pigmentosa

A Phase 1/2 interventional study of BS01 in Retinitis Pigmentosa, sponsored by Bionic Sight LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Bionic Sight LLC · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 8 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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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

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Conditions studied

  • Retinitis Pigmentosa

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03

In context

Retinitis Pigmentosa

268 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.

This study's planned enrollment of 20 is below the median of 27 across 173 interventional studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Bionic Sight LLC is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    BSO1 Cohort 1 dose

    Drug: BS01

  • Experimental
    Cohort 2

    BS01 Cohort 2 dose

    Drug: BS01

  • Experimental
    Cohort 3

    BS01 Cohort 3 dose

    Drug: BS01

  • Experimental
    Cohort 4

    BS01 Cohort4 dose

    Drug: BS01

  • Experimental
    Cohort 5

    BS01 Cohort4 dose

    Drug: BS01

  • Experimental
    Cohort 6

    Treat opposite eye

    Drug: BS01

Interventions

  • DrugBS01

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

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What researchers measure

Primary outcomes

  1. Primary Outcome Measure

    Number of subjects with adverse events, changes in hematology/chemistry

    Time frame: 12 months

Secondary outcomes

  1. Secondary Outcome Measures

    Changes in light detection (threshold to detect) Changes in motion detection Changes in shape/object/letter detection Changes in performance on maze navigation task

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • New Jersey Retina
    Teaneck, New Jersey 07666, United States
    • Lauryn Onkendi · Contact · lonkendi@njretina.com · (201)837-7300
    • Paul Hahn, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04278131
Lead sponsor
Bionic Sight LLC
Responsible party
Sponsor
First posted
Feb 20, 2020
Start date
Feb 6, 2020
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Jan 23, 2026

Study contacts

Minako Koga
Contact
mkoga@kmphc.com
Sheila Nirenberg, PhD
study director · Bionic Sight LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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