Actively Recruiting
Choroidal Melanoma Patient-Reported Outcome Study in a Subset of AU-011-301 (CoMpass) Subjects
Led by Aura Biosciences · Updated on 2026-02-19
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aura Biosciences
Lead Sponsor
V
Vitaccess Ltd
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have enrolled in the Aura-sponsored clinical trial AU-011-301.
- Have access to a connected device such as a smartphone, laptop, or tablet.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (digital)
Duration - Up to 24 months
Participants complete digital surveys to report on symptoms, functional status, and quality of life over time.
Multiple scheduled digital surveys at defined timepoints up to 24 months
Trial Site Locations
Total: 1 location
1
Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
M
Medical Monitor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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