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

Completed · Phase 2

Conditions studied: Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

In brief

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).

Key facts

Study ID

NCT04417530

Run by

Aura Biosciences

People needed

22

Starts

2020-08-05

Expected to finish

2024-04-22

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Have known contraindications or sensitivities to the study drug or laser
• Active ocular disease

Where it is running

• 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

Full record on ClinicalTrials.gov

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