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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Retina Associates SW, P.C.
Tucson, Arizona, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Retina Consultants of Sacramento
Sacramento, California, United States
Colorado Retina Associates
Denver, Colorado, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Start Date
February 27, 2017
Primary Completion Date
January 26, 2021
Completion Date
January 26, 2021
Last Updated
February 1, 2024
57
ACTUAL participants
Light-activated AU-011
DRUG
Laser Activation
DEVICE
Lead Sponsor
Aura Biosciences
NCT06007690
NCT06581406
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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