AURA

Actively Recruiting // Clinical Trials // Melanoma // Michael Altaweel // Sep 28 2020

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 na├»ve 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:

visit clinicaltrials.gov.