- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255032
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis (DOGWOOD)
A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.
The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.
Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
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Georgia
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Atlanta, Georgia, United States, 30322
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Illinois
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Chicago, Illinois, United States, 60611
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Waltham, Massachusetts, United States, 02451
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Nebraska
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Omaha, Nebraska, United States, 68105
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New York
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New York, New York, United States, 10021
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
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North Dakota
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Fargo, North Dakota, United States, 58103
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Ohio
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Cleveland, Ohio, United States, 44195
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Texas
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Dallas, Texas, United States, 75231
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of noninfectious uveitis
- diagnosis of macular edema associated with noninfectious uveitis
Exclusion Criteria:
- any ocular trauma within the immediate 6 months prior to treatment
- any photocoagulation or cryotherapy in the 6 months prior to treatment
- any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
- any eye diseases other than uveitis and ME that could compromise central visual acuity
- any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 4 mg CLS-TA
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
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40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
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Experimental: 0.8 mg CLS-TA
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
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8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
Time Frame: 2 months
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2 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS1001-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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