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

Phase 1

Completed

• Conditions: Uveal Melanoma; Choroid Neoplasm
• Interventions: Biological: ICON-1

• Registration Number: NCT02771340
• Lead Sponsor: Iconic Therapeutics, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-09-14
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICON-1 0.3 mg Singe Dose	ICON-1	Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1 0.3 mg Repeat Dosing	ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1 0.6 mg Repeat Dosing	ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events	30 days (plus or minus 5 days) after surgical procedure

Secondary Outcome Measures

Name	Time	Method
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	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.