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Preventing Neovascular Glaucoma in Patients with Large Choroidal Melanoma Using Aflibercept During Proton Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called neovascular glaucoma, which can occur in patients who have been treated for a type of eye cancer known as large choroid melanoma. This melanoma is a tumor located in the eye, and in this study, it is specifically those that are 7 mm thick or more, or have a basal diameter greater than 15 mm. The treatment for this melanoma involves a type of radiation therapy called proton therapy.

The study is investigating the use of a medication called aflibercept, which is also known by its brand name Eylea. Aflibercept is administered as an injection directly into the eye, known as an intravitreal injection. The purpose of the study is to see if aflibercept can help prevent neovascular glaucoma in patients who have undergone proton therapy for large choroid melanoma. Participants in the study will be divided into two groups: one group will receive the aflibercept injections, while the other group will receive a false injection, known as a placebo.

The study will follow participants for a period of five years after their proton therapy treatment to compare the rate of neovascular glaucoma between the two groups. This will help determine if the preventive use of aflibercept is effective in reducing the occurrence of this eye condition in patients with large choroid melanoma. The study aims to provide valuable insights into the potential benefits of using aflibercept as a preventive treatment in this context.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and the size of the choroid melanoma. The melanoma must be more than 7 mm thick or have a basal diameter over 15 mm, and treatment by proton therapy is required.

  2. Step 2

    Initial treatment

    The initial treatment involves receiving proton therapy. This is a type of radiation therapy used to treat the large choroid melanoma.

  3. Step 3

    Administration of medication

    Following proton therapy, the patient receives intravitreal injections. These injections are administered directly into the eye.

    The medication used is Eylea, which contains the active substance aflibercept. It is a solution for injection provided in a pre-filled syringe.

    The purpose of these injections is to prevent the development of neovascular glaucoma, a condition that can occur after radiation therapy.

  4. Step 4

    Monitoring and follow-up

    The patient is monitored for the occurrence of neovascular glaucoma. This involves regular clinical examinations, including an examination at the slit lamp, which is a microscope with a bright light used to look at the eye.

    The primary goal is to compare the rate of neovascular glaucoma five years after proton therapy between patients receiving the actual medication and those receiving a placebo.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by June 8, 2025. At this point, the final assessments are conducted to determine the effectiveness of the treatment in preventing neovascular glaucoma.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Have a **choroid melanoma** that is more than **7 mm thick** or has a **basal diameter** (the width at the base) of more than **15 mm**.
  • The melanoma must be treated with **proton therapy**, a type of radiation treatment.
  • Both **men and women** can participate.
  • Participants should not be from a **vulnerable population**, meaning they should be able to make decisions for themselves.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of eye condition than the one being studied.
  • Patients who have already received a different treatment for their eye condition.
  • Patients who have other serious health problems that could affect the study results.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the medications used in the study.
  • Patients who have had eye surgery recently.
  • Patients who have an infection in the eye.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

Anti-VEGF is a medication used in this trial to prevent neovascular glaucoma in patients with large choroid melanoma who are undergoing proton therapy. It is administered through injections into the eye. The medication works by blocking a protein called vascular endothelial growth factor (VEGF), which can contribute to the growth of abnormal blood vessels in the eye. By inhibiting VEGF, the medication aims to reduce the risk of developing glaucoma, a condition that can lead to vision loss.

What is already known about the treatment

Anti-VEGF – This medication is administered through intravitreal injections, meaning it is injected directly into the eye. It is currently being studied in clinical trials for its effectiveness in preventing neovascular glaucoma in patients with large choroid melanoma who have undergone proton therapy. The main therapeutic indication is to reduce the risk of developing neovascular glaucoma, a condition that can lead to vision loss. At the molecular level, anti-VEGF works by inhibiting vascular endothelial growth factor (VEGF), a protein that promotes the growth of new blood vessels, which can contribute to eye diseases. It is classified pharmacologically as an anti-angiogenic agent.

Investigated diseases

  • Choroidal Melanoma

    Choroidal melanoma is a type of cancer that occurs in the eye, specifically in the choroid, which is a layer of blood vessels between the retina and the sclera. It is characterized by the growth of malignant cells that can form a tumor. The tumor can vary in size, and in this context, it is described as being 7 mm thick or having a basal diameter of more than 15 mm. As the disease progresses, it can lead to complications such as vision loss or detachment of the retina. The growth of the tumor may also cause pressure within the eye, potentially leading to other eye conditions.

  • Neovascular Glaucoma

    Neovascular glaucoma is a type of glaucoma that occurs when new, abnormal blood vessels grow on the iris and over the eye's drainage channels. This growth can block the normal flow of fluid out of the eye, leading to increased intraocular pressure. The condition often develops as a complication of other eye diseases, such as diabetic retinopathy or retinal vein occlusion. As the disease progresses, the increased pressure can damage the optic nerve, leading to vision loss. Symptoms may include eye pain, redness, and decreased vision.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513746-11-00Protocol code15-API-01Estimated enrolment56 patientsSponsorCentre Hospitalier Universitaire De Nice

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).