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 Intermediate Lesions or Small Choroidal Melanoma
- Sponsor: Aura Biosciences, Inc.
- Principal Investigator: Michael Altaweel, MD
- Study Coordinator: Bonnie Verges
Study Objective:
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).
Study Design:
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.
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
Contact Bonnie Verges with questions, (608) 265-5292
For more information about this study, visit clinicaltrials.gov: https://clinicaltrials.gov/study/NCT06007690?term=AU-011-301&rank=1