Choroidal MelanomaCoMpassNCT07338968

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

An observational study of Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 10 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Choroidal Melanoma, Indeterminate Lesions
What is being tested?: Observational
How many people: 100 participants
Where: 10 sitesUnited States
Study dates: 27 Mar 2026to 15 Aug 2033
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

None

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

10 sites in 1 country

United States10 sites

W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105
Austin Retina Associates Ophthalmology/Retina
Austin, Texas, 78705
Retina Consultants of Carolina
Greenville, South Carolina, 29605
University of Wisconsin Madison
Madison, Wisconsin, 53705
Tennessee Retina, PC
Nashville, Tennessee, 37421
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112
Mayo Clinic
Rochester, Minnesota, 55905
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
Retina Associates of Utah
Salt Lake City, Utah, 84107
Retina Center of Texas
Southlake, Texas, 76092

Other trials in United States

About this study

Official title: A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)

Read the detailed description

Informed consent will be obtained for each subject, preferably during their participation in the AU-011-301 trial and no more than approximately 6 months after their AU-011-301 End of Trial (EoT)/Early Termination (ET) visit. All subjects will be followed for an additional ~5 years (not including AU-011-301 participation). The AU-011-301 assigned subject numbering will continue to be used in this study. The AU-011-301 randomization (treatment received) will continue to be masked during this study until the completion of the AU-011-301 trial and database lock. The purpose of this long-term follow-up study is to learn about how safe and how well bel-sar works over time in people who previously participated in the AU-011-301 study. This will include collecting data from both people who received bel-sar and those who received the sham procedure.

The AU-011-403 study will collect data on:

Long-term safety will be measured by collecting information about any side effects (adverse events) or serious medical problems (serious adverse events) that may occur.

Long-term effectiveness of treatment in AU-011-301 will be measured by looking at any changes in subject's early CM and/or changes in vision over time.

Disease progression, including whether the early CM spreads to other parts of the body (metastasis).

Survival outcomes, including overall survival and disease-specific survival. Long-term quality of life (QoL) will be measured by using questionnaires (EORTC-QLQ-C30 and EORTC-QLQ-OPT30).

This study will help determine how long the effects of bel-sar last and whether any long-term risks or benefits appear after the initial treatment period.

The information collected may also help improve treatment options and strategies for future patients with early CM.

Conditions: Choroidal Melanoma, Indeterminate Lesions
Being tested: Observational
Keywords: Ocular Melanoma, Small Choroidal Melanoma
Medical subject headings: Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202615 Aug 2033

First posted14 Jan 2026
Study start27 Mar 2026
Primary completion15 Aug 2033 (estimated)
Study completion15 Aug 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Choroidal MelanomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07338968
Sponsor's protocol ID: AU-011-403
Acronym: CoMpass
Status last verified: Aug 2026
First submitted: 21 Nov 2025
Last updated: 19 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingPhase 3
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
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingObservational study
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions of Eye
Active, not recruitingPhase 2
Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases
Metastatic Malignant Neoplasm in the Liver, Metastatic Uveal Melanoma

All Choroidal Melanoma trials