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Trial record 1 of 1 for:    NCT04626128
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Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (OASIS)

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ClinicalTrials.gov Identifier: NCT04626128
Recruitment Status : Active, not recruiting
First Posted : November 12, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Brief Summary:
To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: CLS-AX Drug: Anti-VEGF Phase 1 Phase 2

Detailed Description:
Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate three dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Three groups of five participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 (Low Dose)
Subjects will receive a low dose of 0.03mg CLS-AX
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Other Name: axitinib injectable suspension

Drug: Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Other Name: aflibercept (2mg)

Experimental: Cohort 2 (Middle Dose)
Subjects will receive a middle dose of 0.06mg CLS-AX
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Other Name: axitinib injectable suspension

Drug: Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Other Name: aflibercept (2mg)

Experimental: Cohort 3 (High Dose)
Subjects will receive a high dose of 0.1mg CLS-AX
Drug: CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
Other Name: axitinib injectable suspension

Drug: Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Other Name: aflibercept (2mg)




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events [ Time Frame: 12 weeks ]
    The summary of adverse events and serious adverse events will be based on the Safety Population and will be limited to TEAEs. A TEAE is any adverse event occurring on or after the date and time of the SC injection of CLS-AX administration at Baseline (Visit 2) or worsening relative to the pre CLS-AX state.


Secondary Outcome Measures :
  1. Change from baseline in pre injection Intraocular Pressure (IOP) [ Time Frame: Day 1 to Week 12 ]
    Changes from Baseline (Visit 2) pre injection IOP values in the study eye

  2. Incidence of subjects receiving additional intravitreal (IVT) aflibercept injections [ Time Frame: Day 1 to Week 12 ]
    Number of subjects receiving additional intravitreal injections during the course of the study

  3. Incidence of subjects qualifying to receive additional intravitreal (IVT) aflibercept injections [ Time Frame: Day 1 to Week 12 ]
    Number of subjects qualifying to receive additional intravitreal injections during the course of the study

  4. Change from Baseline (Visit 2) in central subfield retinal thickness (CST) in the study eye [ Time Frame: Day 1 to Week 12 ]
    Mean change from Baseline (Visit 2) values in CST during the course of the study

  5. Change from Baseline (Visit 2) in best corrected visual acuity (BCVA) letter score in the study eye [ Time Frame: Day 1 to Week 12 ]
    Mean change from Baseline (Visit 2) values in BCVA during the course of the study.

  6. Maximum plasma concentration [Cmax] of axitinib [ Time Frame: Day 1 to Week 12 ]
    Maximum (or peak) plasma concentration of axitinib during the course of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of neovascular age-related macular degeneration in the study eye.
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Two or more prior anti-VEGF intravitreal injections
  • EDTRS BCVA score ≤ 75 and ≥ 20 letters

Exclusion Criteria:

  • Any active ocular disease, ocular disorders, prior ocular surgery or infection in the study eye other than nAMD
  • Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteriod
  • IOP ≥ 25mmHg or cup-to-disc ratio >0.8
  • Active neovascular AMD in both eyes
  • Any clinically significant disorder or condition or disease (e.g. cardiovascular disease, uncontrolled hyperthyroidism, hyperglycemia, HbA1c >7.0, gastrointestinal bleed) that would make the participant unsuitable for the study
  • Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626128


Locations
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United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
Northern California Retina Vitreous Associates Medical Group, LLC
Mountain View, California, United States, 94040
United States, Maryland
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Thomas Ciulla, MD, MBA Clearside Biomedical, Inc.
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT04626128    
Other Study ID Numbers: CLS1002-101
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clearside Biomedical, Inc.:
AMD
Wet-AMD
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action