Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
NCT ID: NCT02771340
Last Updated: 2020-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2016-05-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICON-1 0.3 mg Singe Dose
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1
Intravitreal injection of ICON-1
ICON-1 0.3 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1
Intravitreal injection of ICON-1
ICON-1 0.6 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1
Intravitreal injection of ICON-1
Interventions
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ICON-1
Intravitreal injection of ICON-1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
* Planned enucleation or brachytherapy of the study eye due to uveal melanoma
Exclusion Criteria
* Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
* Woman who is pregnant or lactating
18 Years
ALL
No
Sponsors
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Iconic Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gabriela Burian, MD
Role: STUDY_DIRECTOR
Iconic Therapeutics, Inc.
Locations
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San Francisco, California, United States
Denver, Colorado, United States
Leawood, Kansas, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Royal Oak, Michigan, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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CURE OM (Community United for Research and Education of Ocular Melanoma)
Ocular Melanoma Foundation (OMF)
Other Identifiers
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IT-003
Identifier Type: -
Identifier Source: org_study_id
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