A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Aura Biosciences
- Study ID
- NCT07338968
- Status
- Enrolling By Invitation
Conditions
- Choroidal Melanoma
- Indeterminate Lesions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Observational — OTHERThe intention is to collect data for an additional \~5 years (Post AU-011-301 participation)
Study Details
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
Key Dates
- First listed
- Jan 14, 2026
- Start date
- Mar 27, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 15, 2033
- Completion
- Aug 15, 2033
Study Design
- Enrollment
- 100 participants (estimated)
Primary Outcome Measure
Incidence of adverse events (AEs)/serious AEs. [ Time Frame: 5 years ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95825 | - |
| W.K. Kellogg Eye Center - University of Michigan | Ann Arbor | Michigan | 48105 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Retina Consultants of Oklahoma | Oklahoma City | Oklahoma | 73112 | - |
| Retina Consultants of Carolina | Greenville | South Carolina | 29605 | - |
| Tennessee Retina, PC | Nashville | Tennessee | 37421 | - |
| Austin Retina Associates Ophthalmology/Retina | Austin | Texas | 78705 | - |
| Retina Center of Texas | Southlake | Texas | 76092 | - |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | - |
| University of Wisconsin Madison | Madison | Wisconsin | 53705 | - |