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.
Study Type
OBSERVATIONAL
Enrollment
500
Retina Associates SW, P.C.
Tucson, Arizona, United States
RECRUITINGUCLA Jules Stein Eye Institute
Los Angeles, California, United States
RECRUITINGByers Eye Institute at Stanford University
Palo Alto, California, United States
RECRUITINGRetina Consultants of Sacramento
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGMassachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
RECRUITINGW. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGAssociated Retinal Consultants, PC
Royal Oak, Michigan, United States
RECRUITINGRetina Center
Minneapolis, Minnesota, United States
RECRUITINGColumbia University Medical Center
New York, New York, United States
RECRUITINGOregon Health & Science University Casey Eye Institute
Portland, Oregon, United States
RECRUITING...and 6 more locations
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar, sham, SoC or alternative treatment.
Time frame: 5 years
Medical Monitor
CONTACT
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