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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: CLS-AX

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Consultants of Arizona
  • California
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates Medical Group, LLC
    • Sacramento, California, United States, 95825
      • Retina Consultants Medical Group, Inc
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Texas
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101; Other Names: axitinib injectable suspension
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; injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101; Other Names: axitinib injectable suspension
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; injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101; Other Names: axitinib injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 1 to Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections	Number of participants qualifying to receive additional intravitreal aflibercept injections during the course of the study. Criteria included 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness >75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye.	Day 1 to Week 24
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)	Intraocular pressure (IOP) is a diagnostic measurement of the fluid pressure, measured in millimeters of mercury, inside the eye. IOP was measured using Goldmann applanation tonometry or by use of a Tonopen tonometer. Normal eye pressure is usually considered to be between 10 and 20 mmHg (AAO.org). Untreated elevated eye pressure is a risk factor for glaucoma.	Weeks 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Clearside Biomedical, Inc.
• Investigators: Study Director: Susan Coultas, PhD, Clearside Biomedical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; AMD; SCS; nAMD; Wet-AMD; suprachoroidal
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: CLS1002-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No