Choroidal Melanoma, Indeterminate Lesions of Eye
Conditions
Keywords
Choroidal Melanoma, Indeterminate Lesions of Eye
Brief summary
The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. The study will collect information based on assessments performed as part of the standard of care (SoC) for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or procedures, information regarding metastatic disease and details of treatments administered, and information about melanoma-related and all-cause mortality and cause of death (if applicable).
Detailed description
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry is 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.
Interventions
None listed
Sponsors
Study design
Eligibility
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 treatment in a previous Aura Biosciences sponsored clinical trial. * Have completed the exit visit of the previous Aura Biosciences sponsored clinical trial within 1 year of Day 1 (≤365 days) of enrollment into the Registry.
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar. | 5 years |
Countries
United States
Contacts
Aura Biosciences Inc.