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

NCT07338968 · tracked via the Priya Life Science USA tracker

Sponsor

Aura Biosciences

Phase

Observational

Started

2026-03-27

Last updated

2026-08-19

Condition(s) studied

Choroidal MelanomaIndeterminate Lesions

Investigational drug(s) / intervention(s)

Observational

Observational: The intention is to collect data for an additional \~5 years (Post AU-011-301 participation)

Study summary

AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. * Be willing and able to consent to the AU-011-403 study. Exclusion Criteria: * None

Primary outcome measure(s)

Incidence of adverse events (AEs)/serious AEs. — 5 years
The AU-011-403 study is the long-term follow-up study of participants previously treated in AU-011-301.Long-term safety will be assessed by measuring the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring during the follow-up period. AEs will be coded using the same Medical Dictionary for Regulatory Activities version used in AU-011-301 (MedDRA)

Trial sites (10)

Facility	City	Region
Retinal Consultants Medical Group, Inc.	Sacramento	California
W.K. Kellogg Eye Center - University of Michigan	Ann Arbor	Michigan
Mayo Clinic	Rochester	Minnesota
Retina Consultants of Oklahoma	Oklahoma City	Oklahoma
Retina Consultants of Carolina	Greenville	South Carolina
Tennessee Retina, PC	Nashville	Tennessee
Austin Retina Associates Ophthalmology/Retina	Austin	Texas
Retina Center of Texas	Southlake	Texas
Retina Associates of Utah	Salt Lake City	Utah
University of Wisconsin Madison	Madison	Wisconsin

More Aura Biosciences trials in the USA

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma Active, not recruiting

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 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 Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma Active, not recruiting

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 NCT07338968 on ClinicalTrials.gov ↗ ← All trials in the USA