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

Clearside Biomedical

Status: Completed

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: CLS-AX

Study type: Observational

Funder types: Industry

Identifiers

NCT05131646

CLS1002-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 3 patient groups

Cohort 2 (Low-mid Dose) Extension

Description:

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.

Treatment:

Drug: CLS-AX

Cohort 3 (High-mid Dose) Extension

Description:

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.

Treatment:

Drug: CLS-AX

Cohort 4 (High Dose) Extension

Description:

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.

Treatment:

Drug: CLS-AX