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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

Uveal Melanoma | Choroidal Melanoma | Ocular Melanoma | Indeterminate Lesions

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).

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Centre Hospitalier de l'Universite Laval
Centre Hospitalier de l'Universite Laval
Québec City, Quebec
Canada

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Princess Margaret Eye Tumour Clinic
Princess Margaret Eye Tumour Clinic
Toronto, Ontario
Canada

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Serac Eye and Skin Care Centre
Serac Eye and Skin Care Centre
Calgary, Alberta
Canada

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Study Sponsored By
Aura Biosciences
Participants Required
More Information
Study ID: NCT06007690