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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)

Clinicaltrials.gov identifier NCT03941379

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted August 7, 2020

Study Description

Brief 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.

  • Condition or Disease:Choroidal Melanoma
    Indeterminate Lesions of Eye
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

This is a multi-center long-term observational Registry of patients with Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs) 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 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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 500 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2029
  • Estimated Study Completion Date: December 2029
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of Treatment Related Adverse Events [ Time Frame: 5 years ]
    Treatment related adverse events will be assessed and graded using CTCAE v5.0. The number and percentage of patients with treatment related adverse events will be summarized.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial.
Criteria

Inclusion Criteria:

- Have been clinically diagnosed with primary CM or IL 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.

Exclusion Criteria:

- None

Contacts and Locations
Contacts

Contact: Rochelle Summerfelt, MS (773) 855-8157 rsummerfelt@aurabiosciences.com

Contact: Abhijit Narvekar, MBBS MS DPM 617-250-7255 anarvekar@aurabiosciences.com

Locations

United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston

United States, Michigan
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor

United States, Michigan
Associated Retinal Consultants, PC
Royal Oak

United States, Minnesota
Retina Center
Minneapolis

United States, Pennsylvania
Wills Eye Hospital
Philadelphia

United States, Texas
Retina Consultants of Houston
Houston

Sponsors and Collaborators

Aura Biosciences

Investigators

Study Director: Abhijit Narvekar, MBBS MS DPM Aura Biosciences Inc.

More Information
  • Responsible Party: Aura Biosciences
  • ClinicalTrials.gov Identifier: NCT03941379 History of Changes
  • Other Study ID Numbers: Registry AU-011-401
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: August 7, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Aura Biosciences: Choroidal Melanoma Indeterminate Lesions of Eye
  • Additional relevant MeSH terms: Melanoma