A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

NCT03941379 · tracked via the Priya Life Science USA tracker

Sponsor

Aura Biosciences

Phase

Observational

Started

2019-03-27

Last updated

2026-05-22

Condition(s) studied

Choroidal MelanomaIndeterminate Lesions of Eye

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (16)

Facility	City	Region
Retina Associates SW, P.C.	Tucson	Arizona
UCLA Jules Stein Eye Institute	Los Angeles	California
Byers Eye Institute at Stanford University	Palo Alto	California
Retina Consultants of Sacramento	Sacramento	California
Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
W. K. Kellogg Eye Center, University of Michigan	Ann Arbor	Michigan
Associated Retinal Consultants, PC	Royal Oak	Michigan
Retina Center	Minneapolis	Minnesota
Columbia University Medical Center	New York	New York
Oregon Health & Science University Casey Eye Institute	Portland	Oregon
Wills Eye Hospital	Philadelphia	Pennsylvania
Retina Consultants of Carolina, PA	Greenville	South Carolina
St. Thomas Health / Tennessee Retina, PC	Nashville	Tennessee
Texas Retina Associates	Dallas	Texas
Retina Consultants of Houston	Houston	Texas
University of Wisconsin	Madison	Wisconsin

More Aura Biosciences trials in the USA

Suprachoroidal Administration in Subjects With Metastases to the Choroid Recruiting

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer Active, not recruiting

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma Enrolling by invitation

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma Active, not recruiting

Other trials for the same condition

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03941379 on ClinicalTrials.gov ↗ ← All trials in the USA