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Clinical trial

OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration

ID
Name
CLS1002-101
Description
To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)
Trial arms
Trial start
2020-12-15
Estimated PCD
2022-10-13
Trial end
2022-10-13
Status
Completed
Phase
Early phase I
Treatment
CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Arms:
Cohort 1 (Low Dose), Cohort 2 (Low-mid Dose), Cohort 3 (High-mid Dose), Cohort 4 (High Dose)
Other names:
axitinib injectable suspension
Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Arms:
Cohort 1 (Low Dose), Cohort 2 (Low-mid Dose), Cohort 3 (High-mid Dose), Cohort 4 (High Dose)
Other names:
aflibercept (2mg)
Size
27
Primary endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Day 1 to Week 12
Number of Participants With Serious Adverse Events
Day 1 to Week 12
Eligibility criteria
Inclusion Criteria: * Diagnosis of neovascular age-related macular degeneration in the study eye. * 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: * Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Four groups of approximately 5 participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}
Updated at
2023-09-18

1 organization

2 products

1 indication

Product
CLS-AX
Indication
Age-Related Macular Degeneration
Product
Anti-VEGF
Organization
Clearside Biomedical