Malignant neoplasm of choroid Trials in Disease

Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions

This clinical trial is investigating a new treatment for patients with small choroidal melanoma or indeterminate lesions in the eye. The condition involves abnormal growths in the choroid, which is a layer of blood vessels between the retina and the outer wall of the eye. Sometimes these lesions are unclear in nature, meaning doctors cannot immediately tell if they are harmless or cancerous. Small choroidal melanoma is a type of eye cancer that starts in the choroid and is characterized by its small size.

Who can participate:

The trial is open to patients who have been diagnosed with a primary indeterminate lesion or small choroidal melanoma that has shown documented early growth. This means scans or examinations have confirmed that the growth has started to increase in size. Patients must not have received any previous treatment for their eye condition, although those who had photodynamic therapy more than 12 months ago may still be considered after consultation with a medical expert. Importantly, imaging tests must confirm that the disease has not spread to other parts of the body. Both male and female patients can participate, and the trial also considers patients from vulnerable populations.

Who cannot participate:

Patients with other eye diseases that could affect the study results are excluded from participation. Those who have had previous treatments for eye tumors, have a history of severe allergic reactions to medications, or are pregnant or breastfeeding cannot join. Additionally, patients with uncontrolled medical conditions that could interfere with the study, those unable to follow study procedures or attend follow-up visits, and patients participating in another clinical trial at the same time are not eligible.

What the study involves:

Participants will be randomly assigned to receive either the investigational drug Belzupacap Sarotalocan (also known as AU-011) or a placebo, which is a sham injection containing no active medication. Neither the patient nor the healthcare team will know which treatment is being given. The medication is delivered through a special injection directly into the eye using a device called the Clearside SCS Microinjector, which places the treatment into a specific area called the suprachoroidal space.

After treatment, patients will be monitored regularly to check how the treatment affects the growth of the tumor and to evaluate vision. The main goal of the study is to measure how long it takes for the tumor to progress, with key assessments taking place at Week 65. The study also tracks visual acuity and any changes in tumor size throughout the monitoring period.

Investigational drug:

Belzupacap Sarotalocan is a targeted cancer therapy that works by binding to cancer cells in the eye. It uses a process called photodynamic therapy, where the medication is activated by light to destroy the cancerous cells while trying to spare healthy tissue. This approach is being tested as a potential new treatment option for patients with these specific eye conditions.

The study is expected to continue until 2027, with recruitment of participants starting in 2024.