Overview
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
Status:
Recruiting
Recruiting
Trial end date:
2027-03-01
2027-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Aura Biosciences
Criteria
Inclusion Criteria:- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Exclusion Criteria:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease