NCT05131646

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CLS-AX	injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2021-11-23
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study