A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Recruiting

• Conditions: Choroidal Melanoma; Indeterminate Lesions of Eye

• Registration Number: NCT03941379
• Lead 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.

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 Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar, sham, SoC or alternative treatment.	5 years

Trial Locations

Locations (16)

Retina Associates SW, P.C.; 🇺🇸 Tucson, Arizona, United States

St. Thomas Health / Tennessee Retina, PC; 🇺🇸 Nashville, Tennessee, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

Associated Retinal Consultants, PC; 🇺🇸 Royal Oak, Michigan, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

UCLA Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

Retina Consultants of Sacramento; 🇺🇸 Sacramento, California, United States

Retina Center; 🇺🇸 Minneapolis, Minnesota, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Oregon Health & Science University Casey Eye Institute; 🇺🇸 Portland, Oregon, United States

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

W. K. Kellogg Eye Center, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Retina Consultants of Carolina, PA; 🇺🇸 Greenville, South Carolina, United States