CoMpass

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 (CoMpass)

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Intraocular melanoma
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All genders
person-wave 18+
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Overview
Principal Investigator: Shilpa Desai, MD

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.

Study details
Inclusion Criteria
  • 1. Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • 2. Have no evidence of metastatic disease confirmed by imaging
  • 3. Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Exclusion Criteria
  • 1.Have known contraindications or sensitivities to the study drug or laser
  • 2. Active ocular infection or disease
Study Requirements

At eligibility visit, visual acuity, ocular imaging including b-scan ultrasound and fluoroscein angiography, and ocular exam assessments. 7 visits in Cycle 1; 5 visits in Cycles 2 and 3 with the same assessments. Randomization to bel-sar/sham treatment (medication and laser). Entire study 104 weeks