Long-Term Follow-Up Study for Uveal Melanoma and Eye Lesion Patients
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
In Plain English
This study is following people like you who participated in a previous Aura Biosciences trial for uveal melanoma (eye cancer) or indeterminate lesions (spots in the eye that doctors are watching). The researchers want to understand how well the treatment worked over many years and whether any side effects develop later on. You're not receiving any new treatment in this study—instead, doctors will simply collect information from your regular eye care and cancer check-up appointments over at least 5 years. This helps Aura Biosciences and the medical community learn what happens to patients long-term, which can help future patients with the same condition.
What This Trial Does
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.
How It Works
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.
Who Can Join
Inclusion Criteria
- 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 bel-sar or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial.
Exclusion Criteria
- \- None
Trial Sites (16)
Retina Associates SW, P.C.
Tucson, Arizona, United States
Amy Merz
RecruitingUCLA Jules Stein Eye Institute
Los Angeles, California, United States
Rosaleen Ostrick
RecruitingByers Eye Institute at Stanford University
Palo Alto, California, United States
Mariana Nunez
RecruitingRetina Consultants of Sacramento
Sacramento, California, United States
Active Not RecruitingMassachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Grayson Hanlon
RecruitingW. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Pamela Campbell
RecruitingAssociated Retinal Consultants, PC
Royal Oak, Michigan, United States
Kendra Mellert
RecruitingRetina Center
Minneapolis, Minnesota, United States
Andi Gilchrist, BS CMSS
RecruitingColumbia University Medical Center
New York, New York, United States
Ellen Alt
RecruitingOregon Health & Science University Casey Eye Institute
Portland, Oregon, United States
Ann Lundquist
RecruitingWills Eye Hospital
Philadelphia, Pennsylvania, United States
Lisa Flynn
RecruitingRetina Consultants of Carolina, PA
Greenville, South Carolina, United States
Lauren Frazier
RecruitingSt. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, United States
Lisa Walden
RecruitingTexas Retina Associates
Dallas, Texas, United States
Sally Arceneaux
RecruitingRetina Consultants of Houston
Houston, Texas, United States
Allison Stroh
RecruitingUniversity of Wisconsin
Madison, Wisconsin, United States
Bonnie Verges
Recruiting