A Phase 2 Trial of AU-011 Via Suprachoroidal Administration with a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
- Sponsor: Aura Biosciences
- Principal Investigator: Michael Altaweel, MD
- Study Coordinator: Bonnie Verges
Study objective:
To assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.
Study design:
Subjects will be randomly assigned to one of six treatment groups. Participation in the study could last up to 7.5 years.
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 naïve for IL/CM
Exclusion criteria:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Contact Bonnie Verges with questions: 608-265-5292. For more information about this study: