Ongoing Clinical Trials for Choroid Melanoma
There are currently 2 ongoing clinical trials for choroid melanoma, a type of eye cancer affecting the choroid layer. These trials are testing new treatments to slow tumor growth and prevent complications like neovascular glaucoma. Trials are taking place across Europe, with participants receiving either investigational treatments or placebo injections while being monitored for safety and effectiveness.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Spain
- Sweden
Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions
This trial is evaluating a new treatment called Belzupacap Sarotalocan (also known as AU-011) for patients with small tumors in the eye or lesions that doctors are not sure whether they are cancerous or not. The medication is delivered directly into a specific part of the eye using a special injector.
Who can join this trial? Participants must have a confirmed diagnosis of a primary indeterminate lesion or small choroidal melanoma that shows documented early growth. This means scans and examinations have shown the lesion or tumor has started to grow. The disease must not have spread to other parts of the body, which will be confirmed through imaging tests. Patients should not have received any previous treatment for their eye condition, although those who had photodynamic therapy more than 12 months ago may still be eligible after discussion with medical experts. Both men and women can participate, including people from vulnerable populations.
Who cannot join? Patients are excluded if they have other eye diseases that might affect the study results, have had previous treatments for eye tumors, have a history of severe allergic reactions to medications, are pregnant or breastfeeding, have uncontrolled medical conditions, cannot follow study procedures or attend follow-up visits, or are participating in another clinical trial simultaneously.
What is the goal? The main purpose of this study is to see if Belzupacap Sarotalocan can slow down or stop the growth of these eye lesions or tumors compared to a placebo injection that contains no active medication. Researchers will monitor participants through regular check-ups to track changes in the eye condition and overall health. The trial will follow participants until 2027 to measure how long it takes for the tumor to progress, with key assessments happening at week 65. The study also looks at visual acuity to ensure the treatment maintains patients’ ability to see clearly.
About the investigational drug: Belzupacap Sarotalocan works by binding to cancer cells and using light activation to destroy them through a process known as photodynamic therapy. This targeted approach aims to destroy cancerous cells while sparing healthy tissue in the eye, potentially offering a new treatment option for patients with these specific eye conditions.
Preventing Neovascular Glaucoma in Patients with Large Choroidal Melanoma Using Aflibercept During Proton Therapy
This trial focuses on preventing a serious complication called neovascular glaucoma that can occur after radiation treatment for large eye tumors. The study tests whether a medication called aflibercept (brand name Eylea) can help prevent this complication in patients receiving proton therapy for large choroidal melanoma.
Who can join this trial? Patients must be at least 18 years old and have a choroidal melanoma that is more than 7 mm thick or has a basal diameter (width at the base) greater than 15 mm. The tumor must be treated with proton therapy, which is a specialized type of radiation treatment. Both men and women can participate, but they should not be from a vulnerable population, meaning they must be able to make decisions for themselves.
Who cannot join? Patients are excluded if they have a different type of eye condition than the one being studied, have already received a different treatment for their eye condition, have other serious health problems that could affect study results, cannot follow study procedures or attend follow-up visits, are pregnant or breastfeeding, are participating in another clinical trial at the same time, have allergies to the medications used in the study, have had recent eye surgery, have an eye infection, or have a history of drug or alcohol abuse.
What is the goal? The study aims to determine whether aflibercept injections given directly into the eye can prevent neovascular glaucoma after proton therapy for large tumors. Neovascular glaucoma occurs when abnormal blood vessels grow on the iris and block fluid drainage from the eye, leading to increased pressure that can damage the optic nerve and cause vision loss. Participants will receive either aflibercept or a placebo injection, and researchers will monitor them for five years to compare the rates of neovascular glaucoma between the two groups. The study is expected to conclude by June 2025.
About the investigational drug: Aflibercept is classified as an anti-VEGF medication, meaning it blocks a protein called vascular endothelial growth factor (VEGF) that promotes the growth of new blood vessels. By inhibiting VEGF, the medication aims to prevent the formation of abnormal blood vessels that lead to glaucoma, thereby reducing the risk of vision loss in patients who have undergone radiation treatment for their eye cancer.
Summary
Currently, two clinical trials are exploring different approaches to treating choroidal melanoma and preventing its complications. The first trial is widely distributed across 12 European countries including Belgium, Ireland, Denmark, Sweden, Czechia, Austria, Netherlands, Germany, Spain, France, Italy, and Greece, focusing on small tumors and indeterminate lesions with a new photodynamic therapy approach. The second trial is conducted exclusively in France and targets patients with larger tumors who need proton therapy, testing whether anti-VEGF medication can prevent a serious complication that threatens vision.
Both trials use injection-based treatments delivered directly into the eye and employ placebo-controlled designs to ensure reliable results. While the first trial focuses on stopping tumor growth in earlier-stage disease, the second trial addresses prevention of complications in more advanced cases requiring radiation therapy. Recruitment for the first study began in 2024 with completion expected in 2027, while the second study is expected to conclude sooner, by mid-2025.
