A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAura Biosciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Subjects who have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. NCT NCT06007690
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionThe intention is to collect data for an additional \~5 years (Post AU-011-301 participation)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)/serious AEs.
The AU-011-403 study is the long-term follow-up study of participants previously treated in AU-011-301.Long-term safety will be assessed by measuring the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring during the follow-up period. AEs will be coded using the same Medical Dictionary for Regulatory Activities version used in AU-011-301 (MedDRA)
Time frame
5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: