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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
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

NCT06007690

Active Not RecruitingPhase 3

Sponsor: Aura Biosciences

Conditions: Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma

Interventions: Bel-sar, Suprachoroidal Microinjector, Infrared Laser, Sham Infrared Laser, Sham Microinjector

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (66)
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Sacramento, California, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Royal Oak, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Greenville, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Southlake, Texas, United States
  • The Woodlands, Texas, United States
  • Salt Lake City, Utah, United States
  • Bellevue, Washington, United States
  • Burlington, Washington, United States
  • + 36 more on CT.gov