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

NCT05131646 | Completed Results FDA Drug

• 1 other identifier: CLS1002-102
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 7

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMD; Wet-AMD; suprachoroidal; tyrosine kinase inhibitor; nAMD; SCS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 to Week 24

Secondary Outcomes (3)

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

  Weeks 4, 8, 12, 16, 20 and 24

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

  Weeks 4, 8, 12, 16, 20 and 24

• Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

  Day 1 to Week 24

Other Outcomes (2)

• Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections

  Day 1 to Week 24

• Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)

  Weeks 4, 8, 12, 16, 20 and 24

Study Arms (3)

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

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

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

Interventions

CLS-AX DRUG

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

Also known as: axitinib injectable suspension

Cohort 2 (Low-mid Dose) Extension; Cohort 3 (High-mid Dose) Extension; Cohort 4 (High Dose) Extension

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who completed cohort 2 or 3 or 4 of CLS1002-101

You may qualify if:

• Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (7)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Northern California Retina Vitreous Associates Medical Group, LLC

Mountain View, California, 94040, United States

Location

Retina Consultants Medical Group, Inc

Sacramento, California, 95825, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Results Point of Contact

• Title: Susan Coultas, PhD
• Organization: Clearside Biomedical, Inc.

susan.coultas@clearsidebio.com

678.270.3639

Study Officials

• Susan Coultas, PhD

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 23, 2021
• Study Start: October 8, 2021
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)