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
Sponsor: Aura Biosciences
ClinicalTrials ID:NCT06007690
This Phase 3 trial assesses the safety and efficacy of bel-sar via suprachoroidal administration and laser activation in patients with primary IL/CM. Eligible participants must have no metastatic disease and be treatment-naive. Interventions include bel-sar with a microinjector and laser, compared to sham procedures.
Patient Parameters
| Parameter | Options |
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Program Overview
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).
Description
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Retina Consultants of Alabama | 35233 | Birmingham | Alabama |
| UCSD Shiley Eye Institute, Jacobs Retina Center | 92093 | La Jolla | California |
| Doris Stein Eye Research Center | 90095 | Los Angeles | California |
| Stanford University School of Medicine | 94303 | Palo Alto | California |
| Retinal Consultants Medical Group, Inc. | 95825 | Sacramento | California |
| Colorado Retina Associates | 80228 | Lakewood | Colorado |
| Bascom Palmer Eye Institute | 33136 | Miami | Florida |
| Retina Associates of Florida, PA | 33609 | Tampa | Florida |
| Emory Eye Center | 30322 | Atlanta | Georgia |
| University of Illinois at Chicago | 60612 | Chicago | Illinois |
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