Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
NCT ID: NCT03097315
Last Updated: 2021-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2017-04-04
2018-01-24
Brief Summary
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Detailed Description
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Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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4 mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
4 mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Interventions
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4 mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ETDRS BCVA score of ≥ 5 letters read in the study eye
Exclusion Criteria
* Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications.
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
18 Years
ALL
No
Sponsors
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Clearside Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Ciulla, MD
Role: STUDY_DIRECTOR
Clearside Biomedical, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Midwest Eye Retina Practicing at Midwest Eye Institute
Indianapolis, Indiana, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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References
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Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology. 1985 Apr;92(4):467-71. doi: 10.1016/s0161-6420(85)34001-0.
Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324.
Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLS1001-302
Identifier Type: -
Identifier Source: org_study_id
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