Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
1 other identifier
interventional
11
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2013
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
2.1 years
February 5, 2013
January 18, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Intraocular Pressure (IOP)
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.
Change from baseline in IOP at 8 weeks
Best Corrected Visual Acuity
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.
Change from baseline at 8 weeks and 26 weeks.
Secondary Outcomes (2)
Central Subfield Thickness Using Optical Coherence Tomography (OCT)
Change from baseline at 8 weeks and 26 weeks.
Vitreous Haze Grade
Change from baseline at 8 weeks and 26 weeks
Study Arms (1)
triamcinolone acetonide (Triesence®)
EXPERIMENTALTRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)
Interventions
4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Eligibility Criteria
You may qualify if:
- diagnosis of non-infectious intermediate, posterior or pan-uveitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northwestern University
Chicago, Illinois, 60611, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Related Publications (1)
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. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec.
PMID: 27980877DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Ciulla, MD
- Organization
- Clearside Biomedical, Inc.
Study Officials
- STUDY DIRECTOR
Thomas Ciulla, MD
Clearside Biomedical, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 12, 2013
Study Start
February 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 21, 2021
Results First Posted
February 21, 2021
Record last verified: 2021-02