The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. The study will collect information based on assessments performed as part of the standard of care (SoC) for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or procedures, information regarding metastatic disease and details of treatments administered, and information about melanoma-related and all-cause mortality and cause of death (if applicable).
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry is 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.
Study Type
OBSERVATIONAL
Enrollment
63
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
...and 6 more locations
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.
Time frame: 5 years
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