Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
NCT ID: NCT02595398
Last Updated: 2021-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2015-11-17
2018-01-18
Brief Summary
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Detailed Description
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Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures 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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham Procedure
Matching suprachoroidal syringe with sham procedure
Sham Procedure
Sham procedure administered at 2 timepoints
Interventions
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4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham Procedure
Sham procedure administered at 2 timepoints
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
* Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye
Exclusion Criteria
* Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg 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 Cuilla, MD, MBA
Role: STUDY_DIRECTOR
Clearside Biomedical, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Retina Centers, PC
Tucson, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
USC Eye Institute
Los Angeles, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Retina Associates
Golden, Colorado, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Center for Retina and Macular Disease
Lakeland, Florida, United States
Emory Eye Center Emory University
Atlanta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Illinois Retina Associates, S.C.
Oak Park, Illinois, United States
Midwest Eye Retina Practicing at Midwest Eye Institute
Indianapolis, Indiana, United States
Elman Retina Group, PA
Baltimore, Maryland, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Valley Eye Physicians and Surgeons, PC
Ayer, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, United States
Discover Vision Centers
Independence, Missouri, United States
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Retina Consultants PLLC
Slingerlands, New York, United States
Charlotte Eye Ear Nose and Throat Associates, PA
Belmont, North Carolina, United States
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Eye Center
Pittsburgh, Pennsylvania, United States
Innovative Clinical Research
Greenville, South Carolina, United States
Austin Retina Associates
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Foresight Studies, LLC
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, United States
L V Prasad Eye Hospital
Hyderabad, Andhra Pradesh, India
Sri Sankaradeva Nethralaya
Guwahati, Assam, India
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, India
JSS Hospital
Mysore, Karnataka, India
Regional Institute of Ophthalmology
Thiruvananthapuram, Kerala, India
TN Medical College and BYL Nair Hospital
Mumbai, Maharashtra, India
PBMA's H V Desai Eye Hospital
Pune, Maharashtra, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
Sankara Eye Hospital
Coimbatore, Tamil Nadu, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Icare Eye Hospital & PG Institute
Noida, Uttar Pradesh, India
Calcutta Medical Research Institute
Kolkata, , India
Disha Eye Hospital
Kolkata, , India
Dr Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi, , India
Dr. Shroff's Charity Eye Hospital
New Delhi, , India
Soroka Medical Center
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Corp
Haifa, , Israel
Hadassah-Hebrew University Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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References
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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.
Bhattacharyya S, Hariprasad SM, Albini TA, Dutta SK, John D, Padula WV, Harrison D, Joseph G. Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis. Value Health. 2022 Oct;25(10):1705-1716. doi: 10.1016/j.jval.2022.07.008. Epub 2022 Aug 31.
Singer MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE. Clin Exp Ophthalmol. 2022 Jan;50(1):23-30. doi: 10.1111/ceo.14024. Epub 2021 Dec 27.
Price KW, Albini TA, Yeh S. Suprachoroidal Injection of Triamcinolone- Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis. US Ophthalmic Rev. 2020 Fall;13(2):76-79. doi: 10.17925/usor.2020.13.2.76. Epub 2020 Dec 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLS1001-301
Identifier Type: -
Identifier Source: org_study_id
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