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Trial record 10 of 958 for:    triamcinolone acetonide

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

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: NCT01789320
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 12, 2013
Last Update Posted Date December 24, 2019
Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
  • Incidence of adverse events [ Time Frame: Number of adverse events at 8 weeks ]
  • Incidence of adverse events [ Time Frame: Number of adverse events at 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
  • Central subfield thickness using optical coherence tomography (OCT) [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ]
  • Vitreous haze grade [ Time Frame: Change from baseline at 8 weeks and 26 weeks ]
  • Change in intraocular pressure (IOP) [ Time Frame: Change from baseline in IOP at 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Official Title  ICMJE Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
Brief Summary This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.
Detailed Description This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uveitis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Panuveitis
  • Noninfectious Uveitis
Intervention  ICMJE Drug: triamcinolone acetonide (Triesence®)
4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Other Names:
  • triamcinolone acetonide
  • TA
  • Triesence
  • corticosteroid
Study Arms  ICMJE Experimental: triamcinolone acetonide (Triesence®)
TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)
Intervention: Drug: triamcinolone acetonide (Triesence®)
Publications * Goldstein DA, Do D, Noronha G, Kissner JM, Srivastava SK, Nguyen QD. Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. Transl Vis Sci Technol. 2016 Dec 14;5(6):14. eCollection 2016 Dec.

*   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 31, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2013)
5
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria:

  • any ocular trauma within the past 6 months in the study eye
  • any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study treatment, or any prior use of Retisert™ in the study eye
  • any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures
  • have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
  • are monocular
  • have ocular hypertension
  • history of any intraocular surgery in the study eye
  • presence of an anterior staphyloma in the study eye
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 NCT01789320
Other Study ID Numbers  ICMJE CLS1001-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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