RecruitingPHASE2, PHASE3INTERVENTIONAL

Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations

This study is investigating a new medication called Bevacizumab for people who have brain arteriovenous malformations (AVMs). Brain AVMs are tangled blood vessels in the brain that can cause serious problems like severe headaches, weakness, or seizures. Currently, surgery or other procedures are the main treatments, but these aren't always possible or safe for everyone, especially if the AVM is large or in a delicate brain area. This research aims to understand if Bevacizumab, which works by reducing blood vessel growth, can effectively reduce the symptoms caused by these AVMs for patients who don't have other treatment options. It's a phase 2/3 study, meaning we're looking at both how well it works and its safety.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrolment target

Start

16 Jan 2026

Estimated completion

15 Jan 2029

Cerebral AV Malformation

What is this study about?

Brain AVMs are unusual tangles of blood vessels in the brain that can cause various health problems. These can range from severe headaches and fits (epilepsy) to difficulties with movement, sensation, or thinking. Sometimes, they can even lead to more serious issues like a bleed in the brain. When a brain AVM causes these types of symptoms, it's called a symptomatic AVM.

Currently, treatments for brain AVMs usually involve procedures like surgery, special injections to block off blood vessels (embolisation), or targeted radiation (radiosurgery). However, these treatments carry their own risks and are often only suitable for smaller AVMs or those in less critical parts of the brain. This means that many people with larger or more complex AVMs, or those in sensitive brain areas, might not have other options to help manage their symptoms.

This study is looking into a new medication called Bevacizumab as a potential treatment for people with symptomatic brain AVMs who cannot have traditional procedures. We know that AVMs involve a lot of new blood vessel growth, and Bevacizumab is a drug designed to slow down this growth. Our aim is to see if this drug can help reduce the disabling symptoms caused by brain AVMs, offering a new possible way to improve the quality of life for those affected.

Key takeaways

This study is testing a new drug for brain AVMs that cause symptoms.
It's for people who can't have traditional surgeries or procedures.
The drug aims to reduce symptoms by targeting abnormal blood vessel growth.
Participants will receive either the active drug or a placebo.
Regular health checks and MRI scans will be part of the study.
Your decision to join or leave the study is entirely yours.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old and have a brain AVM that is causing noticeable symptoms like ongoing headaches, weakness in a part of your body, memory issues, or seizures. Your symptoms must be significant enough that we would expect an improvement with treatment, for instance, if they're affecting your daily life.

It's important that you are not able to have traditional treatments like surgery, targeted radiation, or special injections to block the AVM. We'll also check that your general health is good, particularly your blood, liver, and kidney functions. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception during and for a while after the study.

You wouldn't be able to join if you're allergic to Bevacizumab or similar medications, or if you have certain other health conditions like very high blood pressure that isn't controlled, recent heart problems, or major surgery planned soon. We also can't include you if you can't have an MRI scan of your brain or if a particular dye used in MRI scans (gadolinium) is unsuitable for you.

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 over 18 years old?
Do you have a brain AVM that is causing symptoms?
Are you unable to have surgery or other AVM procedures?
Is your general health, including blood pressure, good?
Are you okay with having regular MRI scans and blood tests?
If you're a woman, are you using effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the study drug, Bevacizumab, or a placebo (a dummy drug with no active ingredients). Both the drug and the placebo are given as an intravenous infusion, which means directly into your vein. Neither you nor your study doctor will know whether you are receiving the active drug or the placebo. You will have regular visits to the clinic for these infusions and for various tests, which may include physical examinations, blood tests, and brain MRI scans. These tests will help us monitor your health, how your AVM is responding, and how your symptoms are changing. The total duration of your participation in the study, including follow-up after your infusions, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a reduction in your AVM symptoms or an improved quality of life, especially if other treatments aren't an option for you. However, there's no guarantee that you will personally benefit from the study treatment. Like all medications, Bevacizumab can have side effects, and while we aim to keep you safe, there are potential risks, which will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

HFAR
Verified postcode
Paris, France· Recruiting

Common questions

What is an AVM?

An AVM (Arteriovenous Malformation) is a rare tangle of abnormal blood vessels in the brain that connects arteries and veins directly, bypassing the normal network of capillaries. This can cause various symptoms and, in some cases, lead to bleeding.

What is Bevacizumab?

Bevacizumab is a medication that works by blocking a protein called VEGF, which helps new blood vessels grow. In this study, we're seeing if it can slow down the abnormal blood vessel growth in AVMs and reduce symptoms.

Will I definitely receive the active medicine?

This study is 'randomised and double-blind', meaning you will be randomly assigned to receive either the active medicine (Bevacizumab) or a placebo (a dummy drug). Neither you nor your doctor will know which one you are receiving.

Are there other treatments for brain AVMs?

Yes, standard treatments include surgery, special injections to block blood vessels (embolization), or targeted radiation (radiosurgery). This study is for people who can't have these other treatments.

How long does the study last?

The study involves regular treatments and check-ups over a period of time, followed by a follow-up period. The exact duration for each participant will be explained by the study team.

How to find out more

Jean-Philippe Désilles, MD, PhD

jpdesilles@for.paris 01 48 03 64 54 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.