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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

Incidence of adverse events (AEs)/serious AEs.

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

617-500-8864

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Official study 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)

Acronym: CoMpass

Important dates

Study start: 2026
Primary completion: 2033
Study completion: 2033
First posted: Jan 14, 2026
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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