A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma

In brief

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Key facts

Study ID

NCT06007690

Run by

Aura Biosciences

People needed

108

Starts

2023-12-06

Expected to finish

2028-08-15

Last updated by the study team

2026-07-31

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 naive for IL/CM (subjects who received PDT may be eligible)

You may not qualify if…

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

Where it is running

• Doris Stein Eye Research Center — Los Angeles, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Retinal Consultants Medical Group, Inc. — Sacramento, California, United States
• Retina Associates of Florida, PA — Tampa, Florida, United States
• Emory Eye Center — Atlanta, Georgia, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Tufts Medical Center New England Eye Center — Boston, Massachusetts, United States
• Massachusetts Eye and Ear — Boston, Massachusetts, United States
• W.K. Kellogg Eye Center - University of Michigan — Ann Arbor, Michigan, United States
• Associated Retinal Consultants (ARC) P.C. — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Nebraska Medicine's Truhlsen Eye Institute — Omaha, Nebraska, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Cole Eye Institute — Cleveland, Ohio, United States
• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Retina Consultants of Oklahoma — Oklahoma City, Oklahoma, United States
• Shields & Shields PC-Wills Eye Institute — Philadelphia, Pennsylvania, United States
• Retina Consultants of Carolina — Greenville, South Carolina, United States
• Southeastern Retina Associates — Chattanooga, Tennessee, United States
• Tennessee Retina, PC — Nashville, Tennessee, United States
• Austin Retina Associates — Austin, Texas, United States
• Texas Retina Associates — Dallas, Texas, United States
• Retina Associates of South Texas, P.A. — San Antonio, Texas, United States
• UCSD Shiley Eye Institute, Jacobs Retina Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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