Title
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

Description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Objective
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).

Treatment Drug: Belzupacap Sarotalocan
Device: Suprachoroidal Microinjector
Device: Infrared Laser
Device: Sham Infrared Laser
Device: Sham Microinjector
Drug: Sham Treatment

Key Eligibility 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)

Have known contraindications or sensitivities to the study drug or laser

Active ocular infection or disease

Applicable Disease Sites
Melanoma/Skin cancer

Participating Institutions
UW Health University Station (UStation)