BS01 for Retinitis Pigmentosa

This study is testing a new treatment called BS01 for people with Retinitis Pigmentosa, an eye disease that causes vision loss. BS01 is a gene therapy that uses a modified virus to deliver a light-sensitive gene into the eye. The goal is to see if BS01 is safe and effective in improving vision. To join, you must have a confirmed diagnosis of Retinitis Pigmentosa and vision no better than 20/160 in at least one eye, or significant peripheral vision loss. The study aims to enroll 20 participants, but its current status is unclear. Researchers will measure the main outcome at 12 months to see how well the treatment works.

Study design
This is a Phase 1/2 interventional study, meaning it's an early-stage trial looking at safety and effectiveness. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess the primary outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04278131

BS01 in Patients With Retinitis Pigmentosa

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bionic Sight LLC
~20 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:BS01

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure
Measured over 12 months
Retinitis Pigmentosa

NCT04278131

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • New Jersey Retina

    Teaneck, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Sheila Nirenberg, PhD · STUDY_DIRECTOR · Bionic Sight LLC

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Eligibility criteria

Inclusion

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

Prior receipt of any AAV gene therapy product
Large amplitude nystagmus
  • Primary Outcome Measure12 months

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