Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
NCT ID: NCT05131646
Last Updated: 2024-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
15 participants
OBSERVATIONAL
2021-10-08
2023-01-05
Brief Summary
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Detailed Description
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Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 2 (Low-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Cohort 3 (High-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Cohort 4 (High Dose) Extension
Subjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Interventions
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CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
* Females of childbearing potential who are pregnant and or lactating.
50 Years
ALL
No
Sponsors
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Clearside Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Coultas, PhD
Role: STUDY_DIRECTOR
Clearside Biomedical, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Northern California Retina Vitreous Associates Medical Group, LLC
Mountain View, California, United States
Retina Consultants Medical Group, Inc
Sacramento, California, United States
Southeast Retina Center
Augusta, Georgia, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLS1002-102
Identifier Type: -
Identifier Source: org_study_id
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