Phase 2 Trial to Evaluate Safety and Efficacy of AU-011 Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Trial ID or NCT#
The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.
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
- - 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
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