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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04278131
Other study ID # BS01-RP-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 6, 2020
Est. completion date December 30, 2029

Study information

Verified date May 2023
Source Bionic Sight LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 30, 2029
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States OCLI New York New York

Sponsors (1)

Lead Sponsor Collaborator
Bionic Sight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure Number of subjects with adverse events, changes in hematology/chemistry 12 months
Secondary Secondary Outcome Measures Changes in light detection by Diagnosys visual function testing
Changes in shape and motion detection by Diagnosys visual function testing
12 months
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