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NCT Number: NCT03941379

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Choroidal Melanoma Eye Diseases Eye Neoplasms Indeterminate Lesions of Eye Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Associates SW, P.C., Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
May 7, 2019
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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