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

Uveal Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771340
• Other study ID #: IT-003
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2020
• Source: Iconic Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroid Neoplasm
• Choroid Neoplasms
• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Biological:
• ICON-1
Intravitreal injection of ICON-1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iconic Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Events		30 days (plus or minus 5 days) after surgical procedure
Secondary	Changes in Plasma Levels of ICON-1.		Baseline to 1 day after last dose of ICON-1
Secondary	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

External Links

•   CURE OM (Community United for Research and Education of Ocular Melanoma)
•   Ocular Melanoma Foundation (OMF)