Status: Recruiting

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).

Participants needed: 100

Trial details

Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Aura BiosciencesUpdated: Mar 2, 2026Locations: 71

Eligibility criteria

Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (... [+2]

Have known contraindications or sensitivities to the study drug or laser [+1]

Status: Recruiting

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.

Participants needed: 15

Trial details

Biological sex: AllType: ObservationalSponsor: Aura BiosciencesUpdated: Feb 19, 2026Locations: 1

Eligibility criteria

Have enrolled in the Aura-sponsored clinical trial AU-011-301. [+1]

None

Status: Not yet recruiting

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

Participants needed: 100

Trial details

Age: 18+Biological sex: AllType: ObservationalSponsor: Aura BiosciencesUpdated: Jan 14, 2026

Eligibility criteria

Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-... [+1]

None