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Spots Global Cancer Trial Database for Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Monitor

Affiliation: Aura Biosciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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