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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 : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date January 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03097315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Suprachoroidal Injection of CLS-TA in Subjects Non-infectious Uveitis
Official Title  ICMJE Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis
Brief Summary Open-label safety study of suprachoroidal triamcinolone acetone injectable suspension in patients with non-infectious uveitis.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uveitis
  • Uveitis, Posterior
  • Uveitis, Anterior
  • Uveitis, Intermediate
  • Panuveitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
Intervention: Combination Product: 4mg CLS-TA Suprachoriodal Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2017)
35
Actual Study Completion Date  ICMJE January 24, 2018
Actual Primary Completion Date January 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03097315
Other Study ID Numbers  ICMJE CLS1001-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clearside Biomedical, Inc.
Study Sponsor  ICMJE Clearside Biomedical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Ciulla, MD Clearside Biomedical, Inc.
PRS Account Clearside Biomedical, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP