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
To assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.
Subjects will be randomly assigned to one of six treatment groups. Participation in the study could last up to 7.5 years.
- 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
- 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: