This clinical trial is focused on studying the treatment of Primary Indeterminate Lesions or Small Choroidal Melanoma, which are conditions affecting the eye. The treatment being tested is called Belzupacap Sarotalocan, also known by its code name AU-011. This medication is administered as a solution for injection using a special device called the Clearside SCS Microinjector, which delivers the medication into a specific part of the eye known as the suprachoroidal space.
The purpose of this study is to evaluate the effectiveness and safety of Belzupacap Sarotalocan compared to a placebo, which is a sham injection that does not contain the active medication. Participants in the study will receive either the active treatment or the placebo. The study will monitor the participants over a period to assess how the treatment affects the progression of the eye condition.
Throughout the study, participants will undergo regular check-ups to track the condition of their eye and overall health. The study aims to determine how well the treatment works in slowing down or stopping the growth of the lesions or melanoma, as well as ensuring that it is safe for use. The trial is expected to continue until 2027, with recruitment starting in 2024.



Austria
Belgium
Czechia
Denmark
France
Germany
Greece
Ireland
Italy
Spain
Sweden
The Netherlands