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Completed

NCT Number: NCT02771340

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

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.

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Key information

Conditions

Uveal Melanoma Choroid Diseases Choroid Neoplasm Choroid Neoplasms Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICON-1

Biological

Intravitreal injection of ICON-1

Other names: human Immuno-conjugate 1

Primary outcomes

  1. Occurrence of Adverse Events

    Time frame: 30 days (plus or minus 5 days) after surgical procedure

Secondary outcomes

  1. Changes in Plasma Levels of ICON-1.

    Time frame: Baseline to 1 day after last dose of ICON-1

  2. Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iconic Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2016
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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