Clinical Trial: Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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-
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.
Detailed Summary:
Sponsor: Iconic Therapeutics, Inc.
Current Primary Outcome: Occurrence of adverse events [ Time Frame: 30 days (plus or minus 5 days) after surgical procedure ]
Original Primary Outcome: Occurrence of adverse events [ Time Frame: Week 8 ]
Current Secondary Outcome:
- Changes in plasma levels of ICON-1 [ Time Frame: 1 day after last dose of ICON-1 ]
- Change in best corrected visual acuity (BCVA) [ Time Frame: On or 1 day prior to surgical procedure day ]
Original Secondary Outcome:
- Changes in plasma levels of ICON-1 [ Time Frame: Day 8 ]
- Change in best corrected visual acuity (BCVA) [ Time Frame: Week 3 ]
Information By: Iconic Therapeutics, Inc.
Dates:
Date Received: May 6, 2016
Date Started: May 2016
Date Completion:
Last Updated: May 11, 2017
Last Verified: May 2017
