Clinical Research Directory

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

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

To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma

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

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.