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Suprachoroidal Injection of CLS-TA in Subjects Non-infectious Uveitis (AZALEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03097315
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Study Description
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Brief Summary:
Open-label safety study of suprachoroidal triamcinolone acetone injectable suspension in patients with non-infectious uveitis.

Condition or disease Intervention/treatment Phase
Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis Combination Product: 4mg CLS-TA Suprachoriodal Injection Phase 3

Detailed Description:
This is a Phase 3, open-label, multi-center study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection for the treatment of subjects with non-infectious uveitis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
 Combination Product: 4mg CLS-TA Suprachoriodal Injection
CLS-TA, 4 mg in 100 microliters, will be administered as a single injection at 2 timepoints
Other Name: Triamcinolone Acetonide


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 24 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), grouped by organ system, relatedness to study medication, and severity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
  • ETDRS BCVA score of ≥ 5 letters read in the study eye

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than uveitis
  • Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
Contacts and Locations
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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): NCT03097315


Locations
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United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States, 94040
United States, Florida
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Marietta Eye Clinic
Marietta, Georgia, United States, 30060
United States, Indiana
Midwest Eye Retina Practicing at Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consultants of Houston
Houston, Texas, United States, 77030
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.
More Information
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03097315     History of Changes
Other Study ID Numbers: CLS1001-302
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Clearside Biomedical, Inc.:
Uveitis
UME
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Panuveitis
Non-infectious Uveitis
 Triamcinolone
Choroid
Choroidal Injection
Suprachoroidal
Microneedle
Microinjection

Additional relevant MeSH terms:
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Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Triamcinolone
Triamcinolone Acetonide
 Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action