Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:May 2016
End Date:September 2017

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A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy

The purpose of this study is to evaluate the safety, tolerability, biological activity,
pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal
doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo
enucleation or brachytherapy of the affected eye.


Inclusion Criteria:

- Males or females of any race at least 18 years of age

- 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:

- Uveal melanoma in the study eye originating in the anterior uveal tract (iris)

- Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

- Woman who is pregnant or lactating
We found this trial at
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