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Completed

NCT Number: NCT05131646

Extension Study to Evaluate the Long-term Outcomes of Subjects 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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinal Consultants of Arizona, Phoenix, Arizona, United States

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLS-AX

Drug

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

Other names: axitinib injectable suspension

Primary outcomes

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

    Time frame: Day 1 to Week 24

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

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Day 1 to Week 24

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

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

    Time frame: Day 1 to Week 24

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

Other outcomes

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

    Time frame: Day 1 to Week 24

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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