BS01 in Patients With Retinitis Pigmentosa
Non-randomized, open label, Phase 1/2 dose escalation study of BS01, a non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP).
Conditions:
🦠 Retinitis Pigmentosa
🗓️ Study Start (Actual) 6 February 2020
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 30 December 2029
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 February 2020
  • First Submitted that Met QC Criteria 18 February 2020
  • First Posted 20 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2023
  • Last Update Posted 3 May 2023
  • Last Verified May 2023