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

Iconic Therapeutics, Inc.0 sites10 target enrollmentMay 2016

ConditionsUveal Melanoma Choroid Neoplasm

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Uveal Melanoma
Sponsor: Iconic Therapeutics, Inc.
Enrollment: 10
Primary Endpoint: Occurrence of Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

September 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Iconic Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurrence of Adverse Events

Time Frame: 30 days (plus or minus 5 days) after surgical procedure

Secondary Outcomes

Changes in Plasma Levels of ICON-1.(Baseline to 1 day after last dose of ICON-1)
Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study(Baseline to on or 1 day prior to surgical procedure day)