Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study

Study Overview
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Brief Summary
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This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.

Detailed Description
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This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.

Official Title
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Extension Study to Evaluate the Long-term Outcomes of Subjects Following CLS-AX Administration for Age-related Macular Degeneration in the CLS-AX CLS1002-101 Study

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: CLS-AX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4. Exclusion Criteria: Received prohibited medication in the Parent study, CLS1002-101. Enrolled in the Parent study CLS1002-101 as part of Cohort 1. Females of childbearing potential who are pregnant and or lactating.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 2 (Low-mid Dose) Extension<br>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. | Drug: CLS-AX<br>* injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101<br>* Other names: axitinib injectable suspension;|
| Cohort 3 (High-mid Dose) Extension<br>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. | Drug: CLS-AX<br>* injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101<br>* Other names: axitinib injectable suspension;|
| Cohort 4 (High Dose) Extension<br>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. | Drug: CLS-AX<br>* injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101<br>* Other names: axitinib injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects experiencing treatment-emergent adverse events (TEAEs) | The number of subjects experiencing treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events are defined as an event that emerges following treatment with CLS-AX (administered at Visit 2 (Baseline, Day 1) of the Parent study, CLS1002-101), having been absent pre-treatment or worsens relative to the pre-treatment state | 24 weeks | 
| The number of subjects experiencing serious adverse events (SAEs) | The number of subjects experiencing serious adverse events (SAEs). Serious adverse events are defined as a serious event that emerges following treatment with CLS-AX (administered at Visit 2 (Baseline, Day 1) of the Parent study, CLS1002-101), having been absent pre-treatment or worsens relative to the pre-treatment state | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in central subfield retinal thickness (CST) in the study eye | Mean change from Baseline in central subfield retinal thickness (CST) in the study eye at Visits 6, 7, and 8 (Weeks 16, 20, and 24). Baseline is defined as the value from Visit 2 (Baseline, Day 1) of the Parent study, CLS1002-101. | 24 weeks | 
| Change from Baseline in best corrected visual acuity letter score in the study eye | Mean change from Baseline in best corrected visual acuity letter score in the study eye at Visits 6, 7, and 8 (Weeks 16, 20, and 24). Baseline is defined as the value from Visit 2 (Baseline, Day 1) of the Parent study, CLS1002-101. | 24 weeks | 
| Incidence of subjects receiving additional therapy in the study eye | Number and percentage of subjects receiving additional therapy in the study eye at Visits 5, 6, 7, and 8 (Weeks 12, 16, 20, and 24). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCS, AMD, Wet-AMD, suprachoroidal, tyrosine kinase inhibitor, nAMD