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The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. 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.
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry will initially be open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions. All subjects 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 subjects with CM or IL.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Retina Associates SW, P.C.
Tucson, Arizona, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Retina Consultants of Sacramento
Sacramento, California, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, United States
Start Date
March 27, 2019
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2029
Last Updated
December 21, 2023
500
ESTIMATED participants
Medical Monitor
CONTACT
Lead Sponsor
Aura Biosciences
NCT06007690
NCT01334008
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04417530