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NCT02771340 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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Recruiting NCT05524935 - Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma Phase 2
Active, not recruiting NCT02913417 - Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases Phase 1/Phase 2
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