RecruitingNCT03941379

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Sponsor

Aura Biosciences

Enrollment

500 participants

Start Date

Mar 27, 2019

Study Type

OBSERVATIONAL

Conditions

Choroidal Melanoma Indeterminate Lesions of Eye

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up registry for patients who previously participated in a clinical trial testing a drug called AU-011 (bel-sar) for eye tumors — specifically indeterminate lesions (spots that may or may not become cancer) or choroidal melanoma (a type of eye cancer). The registry collects ongoing safety and disease status information from these patients over time. **You may be eligible if...** - You previously participated in an Aura Biosciences clinical trial for an eye lesion or choroidal melanoma - You received AU-011 (bel-sar), a placebo, standard of care, or were in an observation group during that prior trial - You are willing to provide ongoing health updates **You may NOT be eligible if...** - You did not participate in a prior Aura Biosciences sponsored clinical trial - You are unwilling or unable to consent to ongoing follow-up Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(16)

University of Wisconsin

Madison, Wisconsin, United States

Columbia University Medical Center

New York, New York, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Associated Retinal Consultants, PC

Royal Oak, Michigan, United States

Retina Associates SW, P.C.

Tucson, Arizona, United States

W. K. Kellogg Eye Center, University of Michigan

Ann Arbor, Michigan, United States

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, United States

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States

St. Thomas Health / Tennessee Retina, PC

Nashville, Tennessee, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Center

Minneapolis, Minnesota, United States

Retina Consultants of Sacramento

Sacramento, California, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Retina Consultants of Houston

Houston, Texas, United States

UCLA Jules Stein Eye Institute

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT03941379

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