Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
NCT ID: NCT04626128
Last Updated: 2023-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2020-12-15
2022-10-13
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 3 (High-mid Dose)
Subjects will receive a high-mid dose of 0.50 mg CLS-AX
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Cohort 4 (High Dose)
Subjects will receive a high-mid dose of 1.0 mg CLS-AX
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Cohort 1 (Low Dose)
Subjects will receive a low dose of 0.03 mg CLS-AX
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Cohort 2 (Low-mid Dose)
Subjects will receive a low-mid dose of 0.10 mg CLS-AX
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Interventions
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CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Two or more prior anti-VEGF intravitreal injections
* EDTRS BCVA score ≤ 75 and ≥ 20 letters
Exclusion Criteria
* Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
* IOP ≥ 25mmHg or cup-to-disc ratio \>0.8
* Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
* Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit
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
California Retina Consultants
Bakersfield, California, United States
Northern California Retina Vitreous Associates Medical Group, LLC
Mountain View, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
San Antonio, 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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CLS1002-101
Identifier Type: -
Identifier Source: org_study_id
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