Phase 1 N=10 Treatment

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

Uveal Melanoma · Choroid Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT02771340 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Sep 2020

Primary outcome: Primary: Occurrence of Adverse Events — 1; 3; 5; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ICON-1 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Iconic Therapeutics, Inc.
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Adverse Events	1; 3; 5; 0; 1; 0	—
SECONDARY Changes in Plasma Levels of ICON-1.	0; 0; 0	—
SECONDARY Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study	-3; -4.3; -3.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02771340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.