Long-Term Follow-Up Study for Uveal Melanoma and Eye Lesion Patients

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Aura BiosciencesN/ARecruiting

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
Age: 18 Years+

Trial Sites (16)

Never sent to our servers

Retina Associates SW, P.C.

Tucson, Arizona, United States

Amy Merz

Recruiting

UCLA Jules Stein Eye Institute

Los Angeles, California, United States

Rosaleen Ostrick

Recruiting

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Mariana Nunez

Recruiting

Retina Consultants of Sacramento

Sacramento, California, United States

Active Not Recruiting

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Grayson Hanlon

Recruiting

W. K. Kellogg Eye Center, University of Michigan

Ann Arbor, Michigan, United States

Pamela Campbell

Recruiting

Associated Retinal Consultants, PC

Royal Oak, Michigan, United States

Kendra Mellert

Recruiting

Retina Center

Minneapolis, Minnesota, United States

Andi Gilchrist, BS CMSS

Recruiting

Columbia University Medical Center

New York, New York, United States

Ellen Alt

Recruiting

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, United States

Ann Lundquist

Recruiting

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Lisa Flynn

Recruiting

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States

Lauren Frazier

Recruiting

St. Thomas Health / Tennessee Retina, PC

Nashville, Tennessee, United States

Lisa Walden

Recruiting

Texas Retina Associates

Dallas, Texas, United States

Sally Arceneaux

Recruiting

Retina Consultants of Houston

Houston, Texas, United States

Allison Stroh

Recruiting

University of Wisconsin

Madison, Wisconsin, United States

Bonnie Verges

Recruiting