Phase 1
Completed N=10
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Uveal Melanoma · Choroid Neoplasm
Source: ClinicalTrials.gov NCT02771340 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Sep 2020
Primary outcomePrimary: Occurrence of Adverse Events — 1; 3; 5; 0 Participants
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.
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 | — |
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
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. Informational only — not medical advice.