Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Tara McCannel, MD (ucla)

Description

Summary

The purpose of this observational research study is to follow participants who have been treated with either AU-011 or observation and/or received standard of care therapy while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness of AU-011 and standard of care therapy. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.

Details

This is a multi-center long-term observational Registry of patients with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry will initially be open to patients who have previously participated in an Aura Biosciences sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions. All patients will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first. No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for patients with CM or IL; these patients are routinely followed at 6-month intervals by their treating physician.

Keywords

Choroidal Melanoma Indeterminate Lesions of Eye Melanoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
  • Have received AU-011 or assigned to an observation cohort in a previous Aura sponsored clinical trial.

You CAN'T join if...

  • None

Locations

  • UCLA Jules Stein Eye Institute accepting new patients
    Los Angeles California 90095 United States
  • Retina Consultants of Sacramento accepting new patients
    Sacramento California 95825 United States

Lead Scientist at UC Cancer

  • Tara McCannel, MD (ucla)
    HS Clinical Professor, Ophthalmology. Authored (or co-authored) 68 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aura Biosciences
Links
Ocular Melanoma
ID
NCT03941379
Study Type
Observational
Last Updated