- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01789320
Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
February 17, 2021 updated by: Clearside Biomedical, Inc.
Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
11
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
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4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline in IOP at 8 weeks
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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.
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Change from baseline at 8 weeks and 26 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline at 8 weeks and 26 weeks.
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Vitreous Haze Grade
Time Frame: Change from baseline at 8 weeks and 26 weeks
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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.
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Change from baseline at 8 weeks and 26 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
February 5, 2013
First Submitted That Met QC Criteria
February 8, 2013
First Posted (Estimate)
February 12, 2013
Study Record Updates
Last Update Posted (Actual)
February 21, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Uveal Diseases
- Choroid Diseases
- Choroiditis
- Uveitis
- Uveitis, Posterior
- Panuveitis
- Uveitis, Intermediate
- Pars Planitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CLS1001-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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