Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

This study has been completed.
Information provided by (Responsible Party):
Clearside Biomedical, Inc. Identifier:
First received: February 5, 2013
Last updated: August 31, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Intermediate Uveitis
Posterior Uveitis
Noninfectious Uveitis
Drug: triamcinolone acetonide (Triesence®)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis

Resource links provided by NLM:

Further study details as provided by Clearside Biomedical, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Number of adverse events at 8 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: Number of adverse events at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Central subfield thickness using optical coherence tomography (OCT) [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ] [ Designated as safety issue: Yes ]
  • Vitreous haze grade [ Time Frame: Change from baseline at 8 weeks and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change in intraocular pressure (IOP) [ Time Frame: Change from baseline in IOP at 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: February 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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

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®.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01789320

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Clearside Biomedical, Inc.
Study Director: Glenn Noronha, PhD Clearside Biomedical, Inc.
  More Information

Responsible Party: Clearside Biomedical, Inc. Identifier: NCT01789320     History of Changes
Other Study ID Numbers: CLS1001-101 
Study First Received: February 5, 2013
Last Updated: August 31, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Clearside Biomedical, Inc.:
intermediate uveitis
posterior uveitis
noninfectious uveitis
suprachoroidal space
ocular inflammatory conditions
triamcinolone acetonide
sympathetic ophthalmia
temporal arteritis
vitreous haze

Additional relevant MeSH terms:
Pars Planitis
Uveitis, Intermediate
Uveitis, Posterior
Choroid Diseases
Eye Diseases
Uveal Diseases
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016