Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
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.
Occurrence of Adverse Events
Changes in Plasma Levels of ICON-1.
Study Arms / Comparison Groups
ICON-1 0.3 mg Singe Dose
Description: Patients will receive a single intravitreal dose of ICON-1 0.3 mg
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
Gabriela Burian, MD, ,
Iconic Therapeutics, Inc.
Gabriela Burian, MD, Study Director, Iconic Therapeutics, Inc.