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NCT03941379 | RECRUITING | Choroidal Melanoma


A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Sponsor:

Aura Biosciences

Brief 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.

Condition or disease

Choroidal Melanoma

Indeterminate Lesions of Eye

Detailed Description:

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
Estimated Enrollment : 500 participants
Official Title : A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Actual Study Start Date : 2019-03-27
Estimated Primary Completion Date : 2029-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Location Details

NCT03941379


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Arizona

Retina Associates SW, P.C.

Tucson, arizona, United States, 85710

RECRUITING

United States, California

UCLA Jules Stein Eye Institute

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Byers Eye Institute at Stanford University

Palo Alto, California, United States, 94303

ACTIVE NOT RECRUITING

United States, California

Retina Consultants of Sacramento

Sacramento, California, United States, 95825

RECRUITING

United States, Massachusetts

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

RECRUITING

United States, road cancer

W. K. Kellogg Eye Center, University of Michigan

Ann Arbor, road cancer, United States, 48105

RECRUITING

United States, road cancer

Associated Retinal Consultants, PC

Royal Oak, road cancer, United States, 48073

RECRUITING

United States, Minnesota

Retina Center

Minneapolis, Minnesota, United States, 55404

RECRUITING

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

RECRUITING

United States, Oregon

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Wills Eye Hospital

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, South Carolina

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States, 29605

RECRUITING

United States, Tennessee

St. Thomas Health / Tennessee Retina, PC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Retina Associates

dallas, Texas, United States, 75231

RECRUITING

United States, Texas

Retina Consultants of Houston

Houston, Texas, United States, 77030

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705

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