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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
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
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
Results First Submitted Date  ICMJE January 18, 2021
Results First Posted Date  ICMJE February 21, 2021
Last Update Posted Date February 21, 2021
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 17, 2021)
  • Change in Intraocular Pressure (IOP) [ Time Frame: Change from baseline in IOP at 8 weeks ]
    Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.
  • Best Corrected Visual Acuity [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ]
    Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
  • Central Subfield Thickness Using Optical Coherence Tomography (OCT) [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ]
    Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
  • Vitreous Haze Grade [ Time Frame: Change from baseline at 8 weeks and 26 weeks ]
    Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.
Original 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 ]
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 Allocation: N/A
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 February 2021

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