A Phase 3 interventional study of Bel-sar and Suprachoroidal Microinjector in Choroidal Melanoma, Indeterminate Lesions and Uveal Melanoma, sponsored by Aura Biosciences. Active, not recruiting at 66 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Aura Biosciences · Phase 3, Interventional, and Treatment
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).
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
103 studies on the registry are indexed under Uveal Melanoma; 38 are open to participants now.
This study's enrollment of 108 is above the median of 42 across 93 interventional studies indexed under Uveal Melanoma.
Browse Uveal Melanoma studies →Aura Biosciences is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
High dose of bel-sar + laser application
Drug: Bel-sar · Device: Suprachoroidal Microinjector · Device: Infrared Laser
Low dose of bel-sar + laser application
Drug: Bel-sar · Device: Suprachoroidal Microinjector · Device: Infrared Laser
Sham injection + sham laser
Device: Sham Infrared Laser · Device: Sham Microinjector
Bel-sar via suprachoroidal administration followed by laser application.
Also known as: AU-011
Suprachoroidal injection device
Also known as: SCS Microinjector
Laser application
Sham laser application
Sham injection device
Time to reach tumor progression
Tumor Progression
Time frame: 65 weeks
Time to composite endpoint
Tumor progression or visual acuity failure
Time frame: 65 weeks
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Aura Biosciences