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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 melanoma.

Recruiting
18 years and older
All
Phase 3

Study Overview: This research is to check how well a new medicine called belzupacap sarotalocan (or bel-sar for short) works and how safe it is. It will be compared to a "sham" treatment, which is like a pretend treatment, in people with certain eye conditions. These conditions are called primary indeterminate lesions (IL) and small choroidal melanoma (CM), which are types of eye growths.

Treatment Process: Bel-sar is given through a special needle that injects the medicine into the eye, specifically in a part called the suprachoroidal space. After the medicine is given, a laser is used to activate it.

  • Study Length: Participants should ask about the number and length of visits needed.
  • Eligibility: Participants must have IL/CM, no spread of the disease, and not previously treated for these conditions.
  • Risks: Possible risks include reactions to the medicine or laser and infections.

Participation: If you have the conditions mentioned and are interested, you could consider joining to help test this new treatment.

Study details
    Choroidal Melanoma
    Indeterminate Lesions
    Uveal Melanoma
    Ocular Melanoma

NCT06007690

Aura Biosciences

20 April 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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