Study of Patient-Reported Outcomes in People With Choroidal Melanoma Enrolled in the AU-011-301 Clinical Trial

What this Trial Is About

Researchers are conducting a patient-reported outcome study to understand the impact of bel-sar treatment on people with choroidal melanoma and related eye melanomas. This study complements the global Phase 3 AU-011-301 clinical trial by collecting real-world information on how treatment affects symptoms, daily functioning, and overall quality of life over time. This is a non-interventional observational study where participants complete surveys online. After confirming eligibility and signing consent, participants will answer custom questions and the EORTC QLQ-OPT30 questionnaire. Surveys are collected at several time points across up to 24 months, capturing the participants experiences without changing their treatment. Participants will access the study through a unique website link and complete screening questions before enrollment. Throughout the study, they will provide information about their health and quality of life using digital surveys. The main outcome measured is the change from baseline in quality of life scores at months 15 and 24. This long-term follow-up helps researchers understand treatment effects from the patient perspective.

Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects