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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
Trial Status: active
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).
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
Additional locations may be listed on ClinicalTrials.gov for NCT06007690.
