Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Other Names:
|
| 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. |
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Other Names:
|
| 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. |
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The number of subjects experiencing treatment-emergent adverse events (TEAEs) [24 weeks]
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
- The number of subjects experiencing serious adverse events (SAEs) [24 weeks]
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
Secondary Outcome Measures
- Change from Baseline in central subfield retinal thickness (CST) in the study eye [24 weeks]
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.
- Change from Baseline in best corrected visual acuity letter score in the study eye [24 weeks]
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.
- Incidence of subjects receiving additional therapy in the study eye [12 weeks]
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).
Other Outcome Measures
- Incidence of subjects meeting the additional therapy criteria in the study eye [8 weeks]
Number and percentage of subjects meeting the additional therapy criteria in the study eye at Visits 6, 7, and 8 (Week 16, 20, and 24).
- Change from baseline in pre injection Intraocular Pressure (IOP) [24 weeks]
Mean change from Baseline in pre injection IOP 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retinal Consultants of Arizona | Phoenix | Arizona | United States | 85014 |
| 2 | Northern California Retina Vitreous Associates Medical Group, LLC | Mountain View | California | United States | 94040 |
| 3 | Cumberland Valley Retina Consultants | Hagerstown | Maryland | United States | 21740 |
| 4 | Retina Consultants of Texas | Bellaire | Texas | United States | 77401 |
| 5 | Retina Consultants of Texas | The Woodlands | Texas | United States | 77384 |
Sponsors and Collaborators
- Clearside Biomedical, Inc.
Investigators
- Study Director: Thomas Ciulla, MD, MBA, Clearside Biomedical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLS1002-102