NCT07338968

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

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

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

Timeline

• Start date: 2026-02-01
• Primary completion: 2033-08-15
• Completion: 2033-08-15
• First posted: 2026-01-14
• Last updated: 2026-01-14