Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Neovascular glaucoma prevention by intravitreal injections of anti-VEGF in patients treated by protontherapy in case of large choroid melanoma

This research study is for people who have a large type of eye cancer called choroid melanoma and are having it treated with a special kind of radiation therapy called proton therapy. After proton therapy, some patients can develop a serious eye problem called neovascular glaucoma. This study wants to find out if giving a medicine called Eylea as an injection into the eye can help prevent this glaucoma from happening. Eylea is already used for other eye conditions. By taking part, patients would help doctors understand if this approach can protect vision for others undergoing similar cancer treatment. It's a Phase 3 study, meaning it's a key step to confirm if the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

01 Oct 2024

Patient with large choroid melanoma 7 mm thick and/or more than 15 mm of basal diameter treated by proton therapy

What is this study about?

Imagine you have a large spot inside your eye, like a mole, but it's a type of cancer called choroid melanoma. Doctors often treat this with a powerful beam of radiation called proton therapy. While very effective against the cancer, sometimes this treatment can lead to another serious eye condition called neovascular glaucoma. This is when new, unwanted blood vessels grow in the eye, causing pressure to build up, which can damage vision.

This study, called a Phase 3 trial, is trying to find a way to stop this neovascular glaucoma from happening in patients who've had proton therapy for their large choroid melanoma. They are looking at a specific medicine called Eylea. Eylea is a drug that blocks the growth of new blood vessels, and it's already used for other eye problems. Researchers want to see if giving Eylea as injections directly into the eye can prevent this glaucoma from developing after proton therapy. This is a crucial step to confirm if this treatment can be helpful for future patients.

The main goal is to check if Eylea can reduce the number of people who get neovascular glaucoma after their proton therapy. Participants will be carefully monitored for signs of this condition using regular eye exams. By being part of this study, you would be contributing to important medical knowledge that could improve the lives and vision of many others undergoing similar cancer treatments in the future.

Key takeaways

This study aims to prevent a serious eye complication (neovascular glaucoma) after proton therapy for large choroid melanoma.
It tests a drug called Eylea, given as eye injections, to see if it can stop this complication.
Participants must have a large choroid melanoma and be having proton therapy.
It's a Phase 3 study, meaning it's a key step to confirm if the treatment works.
Taking part helps advance knowledge for future patients undergoing similar treatments.

Who may be eligible?

This study is looking for adults who have a specific type of eye cancer called choroid melanoma. Your melanoma needs to be quite large – either at least 7mm thick or wider than 15mm across at its base. You must be planned to receive proton therapy, which is a type of radiation treatment, for this melanoma.

You also need to be at least 18 years old. Both men and women can take part in this study. The doctors will do a thorough check to make sure you meet all the necessary requirements to join.

There might be other health conditions or treatments that could mean you can't join the study, even if you meet these main points. The medical team will discuss all of these details with you to ensure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a choroid melanoma that is considered large (7mm thick or wider than 15mm)?
Are you scheduled to receive proton therapy for this melanoma?
Are you able to attend regular eye examinations and study visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive injections of the Eylea medicine directly into your eye. The exact schedule and number of injections would be explained in detail by the study team. You would also have regular check-ups and eye examinations, likely including tests with a special microscope called a slit lamp, to monitor your eye health and to see if neovascular glaucoma develops. These visits would allow the doctors to keep a close eye on your progress and any side effects. The total length of your participation in the study, including follow-up visits, would be clearly outlined before you decide to join.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a treatment that could help prevent a serious eye complication (neovascular glaucoma) after your proton therapy. However, there are no guarantees, and Eylea, like any medicine, can have potential side effects which would be explained to you. These might include discomfort from the eye injections or other eye-related issues. The study team will carefully monitor you for any problems. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a choroid melanoma?

It's a rare type of cancer that develops in a part of the eye called the choroid, which is behind the retina.

What is proton therapy?

It's a highly targeted type of radiation treatment used to destroy cancer cells, often for cancers located in sensitive areas like the eye.

What is neovascular glaucoma?

It's a serious eye condition where abnormal new blood vessels grow in the eye, causing high pressure and potential vision damage.

What is Eylea?

Eylea is a medication injected into the eye to block the growth of new, unwanted blood vessels, often used for other eye conditions.

Will I know if I'm getting the drug or a placebo?

This is a key detail the study team will explain. Sometimes, to test a new treatment, some participants get the active drug and others get a placebo (a dummy treatment) or standard care, but this is always fully explained.