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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join if…

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

Where this trial is running

• Retina Consultants of Alabama, Birmingham, Alabama, United States
• UCSD Shiley Eye Institute, Jacobs Retina Center, La Jolla, California, United States
• 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
• Bascom Palmer Eye Institute, Miami, Florida, 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

+ 59 more sites.

Who to contact

Medical Monitor · 617-500-8864 · clinical@aurabiosciences.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06007690.