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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intravitreal injection of ICON-1
Unnamed facility
San Francisco, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Leawood, Kansas, United States
Unnamed facility
Boston, Massachusetts, United States
Occurrence of Adverse Events
Time frame: 30 days (plus or minus 5 days) after surgical procedure
Changes in Plasma Levels of ICON-1.
Time frame: 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.
Time frame: Baseline to on or 1 day prior to surgical procedure day
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Unnamed facility
Grand Rapids, Michigan, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Philadelphia, Pennsylvania, United States