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Recruiting NCT03941379

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Trial Parameters

Condition Choroidal Melanoma
Sponsor Aura Biosciences
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-03-27
Completion 2029-12

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.

Eligibility 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

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