Health Trials

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

ConditionsChoroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAura Biosciences

About this trial

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

Qualifiers

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)

Disqualifiers

Have known contraindications or sensitivities to the study drug or laser

Active ocular infection or disease

Trial design

Treatments tested in this trial

  • Bel-sar
  • Suprachoroidal Microinjector
  • Infrared Laser
  • Sham Infrared Laser
  • Sham Microinjector

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Aura Biosciences

Lead sponsor

Source ClinicalTrials.gov