Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 35 for:    "Pars planitis"

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01789320
First received: February 5, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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
Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis
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 ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Primary Completion Date: January 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®.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01789320     History of Changes
Other Study ID Numbers: CLS1001-101
Study First Received: February 5, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Clearside Biomedical, Inc.:
intermediate uveitis
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:
Pars Planitis
Chorioretinitis
Panuveitis
Uveitis
Uveitis, Intermediate
Uveitis, Posterior
Choroid Diseases
Choroiditis
Eye Diseases
Retinal Diseases
Retinitis
Uveal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014