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

Sponsor: Aura Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06007690

Patient View

This Phase 3 trial assesses the safety and efficacy of bel-sar via suprachoroidal administration and laser activation in patients with primary IL/CM. Eligible participants must have no metastatic disease and be treatment-naive. Interventions include bel-sar with a microinjector and laser, compared to sham procedures.

Patient Parameters

Program Overview

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).

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.

Eligibility 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

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