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Back|NCT06007690Recruiting
Official Title

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

Phase
Phase 3
Sponsor
Aura Biosciences
Enrollment
100
Timeline
Dec 2023 → Aug 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • 2Have no evidence of metastatic disease confirmed by imaging
  • 3Be treatment naive for IL/CM (subjects who received PDT may be eligible)

Exclusion Criteria

  • 1Have known contraindications or sensitivities to the study drug or laser
  • 2Active ocular infection or disease

Locations

66 sites participating in this study

Emory Eye Center

Atlanta, Georgia 30322

Recruiting

Retina Consultants of Alabama

Birmingham, Alabama 35233

Withdrawn

UCSD Shiley Eye Institute, Jacobs Retina Center

La Jolla, California 92093

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →