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Phase IIIInterventional

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

Protocol: STUDY00006128NCT: NCT06007690

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).

Eligibility

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

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
Investigators
Jill Wells
Location
Winship Cancer Institute
View on ClinicalTrials.gov