Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2020-02-06
2029-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
BSO1 Cohort 1 dose
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Cohort 2
BS01 Cohort 2 dose
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Cohort 3
BS01 Cohort 3 dose
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Cohort 4
BS01 Cohort4 dose
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Cohort 5
BS01 Cohort4 dose
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Cohort 6
Treat opposite eye
BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Interventions
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BS01
Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Eligibility Criteria
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Inclusion Criteria
* 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
* Large amplitude nystagmus
18 Years
ALL
No
Sponsors
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Bionic Sight LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Sheila Nirenberg, PhD
Role: STUDY_DIRECTOR
Bionic Sight LLC
Locations
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New Jersey Retina
Teaneck, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BS01-RP-001
Identifier Type: -
Identifier Source: org_study_id
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