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
Aura Biosciences
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugBel-sar
Bel-sar via suprachoroidal administration followed by laser application.
- DeviceSuprachoroidal Microinjector
Suprachoroidal injection device
- DeviceInfrared Laser
Laser application
- DeviceSham Infrared Laser
Sham laser application
- DeviceSham Microinjector
Sham injection device
Locations (71)
- Retina Consultants of AlabamaBirmingham, Alabama
- UCSD Shiley Eye Institute, Jacobs Retina CenterLa Jolla, California
- Doris Stein Eye Research CenterLos Angeles, California
- Stanford University School of MedicinePalo Alto, California
- Retinal Consultants Medical Group, Inc.Sacramento, California
- Bascom Palmer Eye InstituteMiami, Florida