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Brief Title: Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Official Title: A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Study ID: NCT04417530
Brief Summary: The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
Detailed Description: This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
UCHealth Eye Center, Aurora, Colorado, United States
Retina Associates of Florida, Tampa, Florida, United States
Emory Eye Center, Atlanta, Georgia, United States
University of Illinois At Chicago Illinois Eye and Ear Infirmary, Chicago, Illinois, United States
Midwest Eye Institute, Carmel, Indiana, United States
University of Iowa Department of Ophthalmology and Visual Sciences, Iowa City, Iowa, 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
Dean McGee Eye Institute, Oklahoma City, Oklahoma, United States
Oregon Health & Science University Casey Eye Institute, Portland, Oregon, United States
Wills Eye Hospital, Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina, PA, Greenville, South Carolina, United States
St. Thomas Health / Tennessee Retina, PC, Nashville, Tennessee, United States
Texas Retina Associates, Dallas, Texas, United States
Retina Consultants of Houston, Houston, Texas, United States
University of Wisconsin Dept of Ophthalmology & Visual Sciences, Madison, Wisconsin, United States
Name: Medical Monitor
Affiliation: Aura Biosciences
Role: STUDY_DIRECTOR