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).

Study Overview

• Status: Active, not recruiting
• Conditions: 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 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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Retina Associates SW, P.C.
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Jules Stein Eye Institute
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford University
    • Sacramento, California, United States, 95825
      • Retina Consultants of Sacramento
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • W. K. Kellogg Eye Center, University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Retina Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University Casey Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Retina Consultants of Carolina, PA
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • St. Thomas Health / Tennessee Retina, PC
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects previously participated in an Aura Biosciences bel-sar study; Subjects with Choroidal Melanoma or Indeterminate Lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.	5 years

Collaborators and Investigators

• Sponsor: Aura Biosciences
• Investigators: Study Director: Medical Monitor, Aura Biosciences Inc.

Publications and helpful links

Helpful Links

• Ocular Melanoma

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Choroidal Melanoma; Indeterminate Lesions of Eye
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Uveal Diseases; Melanoma; Uveal Neoplasms; Uveal Melanoma
• Other Study ID Numbers: Registry AU-011-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No