Suprachoroidal Injection of CLS-TA in Subjects Non-infectious Uveitis (AZALEA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03097315 |
Recruitment Status :
Completed
First Posted : March 31, 2017
Last Update Posted : December 20, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis | Combination Product: 4mg CLS-TA Suprachoriodal Injection | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis |
Actual Study Start Date : | April 1, 2017 |
Actual Primary Completion Date : | January 24, 2018 |
Actual Study Completion Date : | January 24, 2018 |

Arm | Intervention/treatment |
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Experimental: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
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Combination Product: 4mg CLS-TA Suprachoriodal Injection
CLS-TA, 4 mg in 100 microliters, will be administered as a single injection at 2 timepoints
Other Name: Triamcinolone Acetonide |
- Adverse Events [ Time Frame: 24 weeks ]Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), grouped by organ system, relatedness to study medication, and severity

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
- ETDRS BCVA score of ≥ 5 letters read in the study eye
Exclusion Criteria:
- Any active ocular disease or infection in the study eye other than uveitis
- Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye
- Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097315
United States, Arizona | |
Retinal Consultants of Arizona | |
Phoenix, Arizona, United States, 85014 | |
United States, California | |
Retina-Vitreous Associates Medical Group | |
Beverly Hills, California, United States, 90211 | |
Northern California Retina Vitreous Associates Medical Group, Inc. | |
Mountain View, California, United States, 94040 | |
United States, Florida | |
Retina Group of Florida | |
Fort Lauderdale, Florida, United States, 33308 | |
United States, Georgia | |
Marietta Eye Clinic | |
Marietta, Georgia, United States, 30060 | |
United States, Indiana | |
Midwest Eye Retina Practicing at Midwest Eye Institute | |
Indianapolis, Indiana, United States, 46290 | |
United States, Massachusetts | |
Ophthalmic Consultants of Boston | |
Boston, Massachusetts, United States, 02114 | |
United States, Texas | |
Texas Retina Associates | |
Dallas, Texas, United States, 75231 | |
Retina Consultants of Houston | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Eye Consultants | |
Norfolk, Virginia, United States, 23502 |
Study Director: | Thomas Ciulla, MD | Clearside Biomedical, Inc. |
Responsible Party: | Clearside Biomedical, Inc. |
ClinicalTrials.gov Identifier: | NCT03097315 |
Other Study ID Numbers: |
CLS1001-302 |
First Posted: | March 31, 2017 Key Record Dates |
Last Update Posted: | December 20, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Uveitis UME Posterior Uveitis Anterior Uveitis Intermediate Uveitis Panuveitis Non-infectious Uveitis |
Triamcinolone Choroid Choroidal Injection Suprachoroidal Microneedle Microinjection |
Uveitis Panuveitis Uveitis, Posterior Uveitis, Intermediate Pars Planitis Uveitis, Anterior Uveal Diseases Eye Diseases Choroiditis Choroid Diseases Triamcinolone Triamcinolone Acetonide |
Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |