BS01 in Patients With Retinitis Pigmentosa

Part of paid clinical trials in Teaneck, New Jersey.

Sponsor
Bionic Sight LLC
Study ID
NCT04278131
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Retinitis Pigmentosa

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BS01 — DRUG
    Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)

Study Details

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

Key Dates

Start date
Feb 6, 2020
Status verified
Jan 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New Jersey RetinaTeaneckNew Jersey07666
Lauryn Onkendi
[email protected]
(201)837-7300
Paul Hahn, MD (PRINCIPAL_INVESTIGATOR)

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New Jersey Retina· Teaneck, NJ

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