Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
- Registration Number
- NCT05131646
- Lead Sponsor
- Clearside Biomedical, Inc.
- 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.
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2 (Low-mid Dose) Extension CLS-AX 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. Cohort 3 (High-mid Dose) Extension CLS-AX 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. Cohort 4 (High Dose) Extension CLS-AX 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs) Day 1 to Week 24 The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Day 1 to Week 24 The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
- Secondary Outcome Measures
Name Time Method Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections Day 1 to Week 24 Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye Weeks 4, 8, 12, 16, 20 and 24 Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A central reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye Weeks 4, 8, 12, 16, 20 and 24 BCVA measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Trial Locations
- Locations (6)
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Retina Consultants Medical Group, Inc
🇺🇸Sacramento, California, United States
Northern California Retina Vitreous Associates Medical Group, LLC
🇺🇸Mountain View, California, United States