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

NCT07338968 | Enrolling By Invitation

• 1 other identifier: AU-011-403
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Choroidal Melanoma; Indeterminate Lesions

Keywords

Ocular Melanoma; Small Choroidal Melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)/serious AEs.

  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)

  5 years

Interventions

Observational OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. NCT NCT06007690

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Aura Biosciences: lead

Study Sites (10)

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95825, United States

Location

W.K. Kellogg Eye Center - University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Retina Consultants of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

Location

Retina Consultants of Carolina

Greenville, South Carolina, 29605, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37421, United States

Location

Austin Retina Associates Ophthalmology/Retina

Austin, Texas, 78705, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location

Related Links

• Aura Biosciences

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Medical Monitor

  Aura Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 14, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): August 15, 2033
• Study Completion (Estimated): August 15, 2033
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)