Study in Subjects With Small Primary Choroidal Melanoma
A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma. Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
Phase 1/Phase 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Study Arms / Comparison Groups
Single Low Dose Light-activated AU-011
Description: Low dose Light-activated AU-011 followed by a single laser light application
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
February 27, 2017
January 26, 2021
Primary Completion Date
January 26, 2021
Inclusion Criteria: - Diagnosis of choroidal melanoma Exclusion Criteria: - Have known contraindications or sensitivities to the study drug
18 Years - N/A
Accepts Healthy Volunteers
Abhijit Narvekar, MBBS, ,
Abhijit Narvekar, MBBS, Study Director, Aura Biosciences