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

Clearside Biomedical, Inc.15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neovascular Age-related Macular Degeneration

Interventions

CLS-AXDRUG

injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (7)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Northern California Retina Vitreous Associates Medical Group, LLC

Mountain View, California, United States

Retina Consultants Medical Group, Inc

Sacramento, California, United States

Southeast Retina Center

Augusta, Georgia, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.

Time frame: Day 1 to Week 24

Number of Participants With Serious Adverse Events (SAEs)

The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.

Time frame: Day 1 to Week 24

Secondary Outcomes

Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye

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.

Time frame: Weeks 4, 8, 12, 16, 20 and 24

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye

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.

Time frame: Weeks 4, 8, 12, 16, 20 and 24

Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.

Time frame: Day 1 to Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.