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

Study 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.

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-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy

Conditions
-----------------
Uveal Melanoma, Choroid Neoplasm

Intervention / Treatment
-----------------
* Biological: ICON-1


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICON-1 0.3 mg Singe Dose<br>Patients will receive a single intravitreal dose of ICON-1 0.3 mg | Biological: ICON-1<br>* Intravitreal injection of ICON-1<br>* Other names: human Immuno-conjugate 1;|
| Experimental: ICON-1 0.3 mg Repeat Dosing<br>Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart | Biological: ICON-1<br>* Intravitreal injection of ICON-1<br>* Other names: human Immuno-conjugate 1;|
| Experimental: ICON-1 0.6 mg Repeat Dosing<br>Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart | Biological: ICON-1<br>* Intravitreal injection of ICON-1<br>* Other names: human Immuno-conjugate 1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events |  | 30 days (plus or minus 5 days) after surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Best-corrected visual acuity (BCVA) will be measured for each eye, pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS)-like retro-illuminated charts. BCVA will be recorded as the total letter score in each eye. | Baseline to on or 1 day prior to surgical procedure day |