Long-term follow-up of people treated for early choroidal melanoma in the CoMpass trial
Follows adults with early choroidal melanoma who finished the earlier bel-sar trial.
Key facts
- Who runs it
- Aura Biosciences
- Where
- Ann Arbor, Austin, Greenville, Madison, Nashville, Oklahoma City, Rochester, Sacramento, Salt Lake City, and Southlake, United StatesSee the 10 sitesAlso in 8 other countries, 21 sites
- Trial code
- Registry title
- A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
- Status
- Enrolling by invitation
- Phase
- Phase 3
- People taking part
- 100 people, planned
- Started
- 27 Mar 2026
- Expected to end
- 15 Aug 2033
- Type of study
- Observational
- Treatments tested
- Observational
- Record updated
- 19 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with early choroidal melanoma who took part in the earlier AU-011-301 trial and received bel-sar or sham treatment there. It is a long-term follow-up with no required treatment.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Early choroidal melanoma (indeterminate lesions or small choroidal melanomas), as studied in the AU-011-301 trial.
- Earlier treatment
- Must have received bel-sar or sham treatment in the AU-011-301 trial.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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 take part
- None
Where in United States
Also in 8 other countries, 21 sites
- W.K. Kellogg Eye Center - University of MichiganAnn Arbor, United StatesNo longer taking part
- Austin Retina Associates Ophthalmology/RetinaAustin, United StatesNo longer taking part
- Retina Consultants of CarolinaGreenville, United StatesNo longer taking part
- University of Wisconsin - MadisonMadison, United StatesNo longer taking part
- Tennessee Retina, PCNashville, United StatesNo longer taking part
- Retina Consultants of OklahomaOklahoma City, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Retinal Consultants Medical Group, Inc.Sacramento, United StatesNo longer taking part
- Retina Associates of UtahSalt Lake City, United StatesNo longer taking part
- Retina Center of TexasSouthlake, United StatesNo longer taking part
About the trial
What the trial wants to find out
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
Treatments tested
- Observational
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Long-term follow-up of people treated for early choroidal melanoma in the CoMpass trialGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 19 August 2026