Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
NCT ID: NCT02303184
Last Updated: 2021-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2015-01-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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4 mg CLS-TA + IVT aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
IVT aflibercept
2 mg intravitreal injection of aflibercept
sham + IVT aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Sham
suprachoroidal sham procedure
IVT aflibercept
2 mg intravitreal injection of aflibercept
Interventions
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4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Sham
suprachoroidal sham procedure
IVT aflibercept
2 mg intravitreal injection of aflibercept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of ME ≤ 12 months
* 20-70 letters inclusive BCVA using ETDRS
Exclusion Criteria
* has had a corticosteroid injection in the past 3 months in the study eye
* any uncontrolled ophthalmic condition in the study eye other than RVO
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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Phoenix, Arizona, United States
Beverly Hills, California, United States
San Diego, California, United States
Boynton Beach, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Winston-Salem, North Carolina, United States
Rapid City, South Dakota, United States
Abilene, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Countries
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Other Identifiers
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CLS1003-201
Identifier Type: -
Identifier Source: org_study_id
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