RecruitingPhase 3NCT06007690
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
Enrollment
100 participants
Start Date
Dec 6, 2023
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria2
- 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)
View Full Details on ClinicalTrials.gov
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NCT06007690
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