Phase 3 Study Comparing Belzupacap Sarotalocan Treatment to Sham Control for Small Choroidal Melanoma or Indeterminate Lesions

Sponsor: Aura Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06007690

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment, belzupacap sarotalocan, for patients with small choroidal melanoma or indeterminate lesions in the eye, compared to a sham control.

Patient Parameters

Program Overview

The main goal of this study is to see if belzupacap sarotalocan (bel-sar) is safe and works well for treating small choroidal melanoma or indeterminate lesions in the eye. The treatment involves injecting the bel-sar drug into the eye and activating it with a laser.

Description

This study is designed to test a new treatment called belzupacap sarotalocan (bel-sar) for people with small choroidal melanoma or indeterminate lesions in the eye. Participants will be randomly assigned to receive either the bel-sar treatment or a sham control, which means they will not receive the active treatment. The bel-sar treatment is given through an injection into the eye, specifically into the space behind the eye, using a special device. After the injection, a laser is used to activate the drug. The study is masked, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the sham control, to ensure unbiased results.

Eligibility Criteria

Inclusion Criteria

  • Have a clinical diagnosis of a small choroidal melanoma or an indeterminate lesion in the eye.
  • No signs of cancer spreading to other parts of the body, confirmed by imaging tests.
  • Have not received any treatment for the eye condition, although those who had photodynamic therapy (PDT) might still be eligible.

Exclusion Criteria

  • Have known allergies or sensitivities to the study drug or the laser used in the treatment.
  • Have an active eye infection or disease.

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