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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

Testing Belzupacap Sarotalocan for eye lesions or small melanomas.

Recruiting
18 years and older
All
Phase 3

This study is testing a new treatment called belzupacap sarotalocan (bel-sar) against a sham control (a fake treatment) for people with eye problems known as primary indeterminate lesions (IL) or small choroidal melanoma (CM). The treatment is done using a special tool called a suprachoroidal (SC) microinjector that puts the medicine in a specific part of the eye. A laser then helps to activate the medicine. If you join the study, you will be randomly assigned to get either the real treatment or the sham. You must have been diagnosed with IL or CM and have no signs of cancer spreading. You should not have had treatment for IL or CM before, except for a specific type called PDT. You cannot join if you have other eye infections or are allergic to the study medicine or laser.

  • The study checks how safe and effective bel-sar is.
  • Participants must have specific eye conditions but no spreading cancer.
  • Participants should not have certain allergies or other eye problems.
Study details
    Choroidal Melanoma
    Indeterminate Lesions
    Uveal Melanoma
    Ocular Melanoma

NCT06007690

Aura Biosciences

16 February 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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