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Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

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ClinicalTrials.gov Identifier: NCT01789320
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Uveitis Intermediate Uveitis Posterior Uveitis Panuveitis Noninfectious Uveitis Drug: triamcinolone acetonide (Triesence®) Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Number of adverse events at 8 weeks ]
  2. Incidence of adverse events [ Time Frame: Number of adverse events at 6 months ]

Secondary Outcome Measures :
  1. Central subfield thickness using optical coherence tomography (OCT) [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ]
  2. Vitreous haze grade [ Time Frame: Change from baseline at 8 weeks and 26 weeks ]
  3. Change in intraocular pressure (IOP) [ Time Frame: Change from baseline in IOP at 8 weeks ]


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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 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

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): NCT01789320


Locations
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.
Investigators
Study Director: Glenn Noronha, PhD Clearside Biomedical, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01789320     History of Changes
Other Study ID Numbers: CLS1001-101
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Clearside Biomedical, Inc.:
uveitis
intermediate uveitis
posterior uveitis
panuveitis
noninfectious uveitis
microneedle
suprachoroidal space
SCS
inflammation
ocular inflammatory conditions
triamcinolone acetonide
TA
Triesence
injection
IVT
intravitreal
corticosteroid
sympathetic ophthalmia
temporal arteritis
vitreous haze

Additional relevant MeSH terms:
Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
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