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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Medical Monitor 617-500-8864
clinical@aurabiosciences.com


Study Location:

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Be Part of Research - Trial Details - 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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Melanoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 Mar 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Bel-sar via suprachoroidal administration followed by laser application.

Intervention Arm Group : High dose bel-sar treatment arm & laser application;Low dose bel-sar treatment arm & laser application;

Intervention Type : DEVICE
Intervention Description : Suprachoroidal injection device

Intervention Arm Group : High dose bel-sar treatment arm & laser application;Low dose bel-sar treatment arm & laser application;

Intervention Type : DEVICE
Intervention Description : Laser application

Intervention Arm Group : High dose bel-sar treatment arm & laser application;Low dose bel-sar treatment arm & laser application;

Intervention Type : DEVICE
Intervention Description : Sham laser application

Intervention Arm Group : Sham control arm & sham laser;

Intervention Type : DEVICE
Intervention Description : Sham injection device

Intervention Arm Group : Sham control arm & sham laser;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Moorfields Eye Hospital NHS Foundation Trust
    London
    EC1V 2PD
  • Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital
    Liverpool
    England
    L7 8XP
  • Nhs Foundation Trust - Royal Hallamshire Hospital
    Sheffield
    S10 2JF


The study is sponsored by Aura Biosciences




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Read full details for Trial ID: NCT06007690
Last updated 15 April 2025

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