Cerebral AV MalformationPhase 2/3BevacizuMAVNCT06264531
Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations
A Phase 2/3 study testing Bevacizumab in people with Cerebral AV Malformation, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral AV Malformation
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2026to 15 Jan 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- With a symptomatic cerebral AVM (chronic headache, focal neurological deficit, cognitive impairment, epilepsy) of Spetzler and Martin grade III, IV or V.
- Whose symptoms are sufficiently severe to allow significant improvement with treatment:
- MoCA score ≤ 25 and/or
- NIHSS score ≥ 4 and/or
- Epilepsy Balance Score ≥ 2 and/or
Show all 13Show fewer
- HIT-6 score ≥ 48
- With functional signs and symptoms not sequellar to a previous bleeding episode AND disabling (mRS>1)
- Ineligible for therapeutic intervention (endovascular or neurosurgery or radiosurgery)
- With normal bone marrow, liver and kidney function
- For women of childbearing potential: negative pregnancy test within 14 days of inclusion and effective contraception for up to 6 months after the end of treatment
- Having received informed consent to participate in the study
- Affiliated or beneficiary of a social security scheme
Who cannot join
- Known allergy to bevacizumab or an excipient.
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
- Contraindication to cerebral MRI
- Absolute or relative contraindication to gadolinium injection
- Proteinuria ≥ 2+ on urine dipstick (patients with proteinuria ≥2+ on urine dipstick will need to have proteinuria ≤ 1g protein on 24-hour urine to be eligible)
- Uncontrolled hypertension (PAS >150 and/or PAD > 100 mmHg)
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- History of hypertensive crisis or hypertensive encephalopathy
- Congestive heart failure (New York Heart Association Grade II or higher)
- Previous myocardial infarction or unstable angina in the preceding 12 months
- Symptomatic peripheral vascular disease
- Vascular disease (aortic aneurysm, aortic dissection)
- Major surgery, open biopsy or major traumatic lesion within 4 weeks prior to inclusion, or anticipation of the need for major surgery during the study.
- Biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to inclusion
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 6 months prior to inclusion
- Significant unhealed wound, ulcer or bone fracture
- Thrombotic episode within 6 months prior to inclusion
- Atrial fibrillation
- Patient under legal protection
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
HFAR
Paris, Île-de-France Region, 75019
Jean-Philippe Désilles, MD, +33148036913, jpdesilles@for.paris
About this study
Official title: Evaluation of the Efficacy and Safety of Anti-angiogenic Therapy With Intravenous Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations
Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.
Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.
The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs.
- Conditions
- Cerebral AV Malformation
- Being tested
- Bevacizumab, Placebo
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab 5 mg/kg as a slow infusion over 90 minutes every 14 days for a total of 6 injections
PlaceboDrug
NaCl 0.9% slow infusion over 90 minutes every 14 days for a total of 6 injections
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | Bevacizumab 5 mg/kg as a slow infusion over 90 minutes every 14 days for a total of 6 injections Receives: Drug: Bevacizumab |
| placebo | Placebo comparator | NaCl 0.9% as a slow infusion over 90 minutes every 14 days for a total of 6 injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches.
Proportion of patients showing at least one of the following improvements :
- change of at least 5 points in Montreal Cognitive Assessment score (from 0 to 30 ; higher score meaning a better outcome)
- change of at least 4 points in National Institutes of Health Stroke Scale ( from 0 to 42 : higher score meaning a worse outcome)
- change of at least one stage on the Epilepsy Balance Score (from 1 to 5 ; higher score meaning a worse outcome)
- change of at least 12 points on the Headache ImpactTest-6 score (from 36 to 78 : higher score meaning a worse outcome)
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start16 Jan 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AV MalformationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264531
- Sponsor's protocol ID
- JDS_2023_12
- Acronym
- BevacizuMAV
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Anti-angiogenic Therapy With Intravenous Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT06264531
- Acronym / sponsor ID
- BevacizuMAV / JDS_2023_12
- Conditions
- Cerebral AV Malformation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.
Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.
The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: BevacizumabBevacizumab 5 mg/kg as a slow infusion over 90 minutes every 14 days for a total of 6 injections |
| placebo | Placebo comparator | Drug: PlaceboNaCl 0.9% as a slow infusion over 90 minutes every 14 days for a total of 6 injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient over 18 years of age
- With a symptomatic cerebral AVM (chronic headache, focal neurological deficit, cognitive impairment, epilepsy) of Spetzler and Martin grade III, IV or V.
- Whose symptoms are sufficiently severe to allow significant improvement with treatment:
- With functional signs and symptoms not sequellar to a previous bleeding episode AND disabling (mRS>1)
- Ineligible for therapeutic intervention (endovascular or neurosurgery or radiosurgery)
Key exclusion criteria (19 listed)
- Known allergy to bevacizumab or an excipient.
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
- Contraindication to cerebral MRI
- Absolute or relative contraindication to gadolinium injection
- Proteinuria ≥ 2+ on urine dipstick (patients with proteinuria ≥2+ on urine dipstick will need to have proteinuria ≤ 1g protein on 24-hour urine to be eligible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabBevacizumab 5 mg/kg as a slow infusion over 90 minutes every 14 days for a total of 6 injections | Drug | bevacizumab |
| PlaceboNaCl 0.9% slow infusion over 90 minutes every 14 days for a total of 6 injections | Drug | placebo |
Primary outcome
Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches.
Time frame: month 6
Proportion of patients showing at least one of the following improvements : * change of at least 5 points in Montreal Cognitive Assessment score (from 0 to 30 ; higher score meaning a better outcome) * change of at least 4 points in National Institutes of Health Stroke Scale ( from 0 to 42 : higher score meaning a worse outcome) * change of at least one stage on the Epilepsy Balance Score (from 1 to 5 ; higher score meaning a worse outcome) * change of at least 12 points on the Headache ImpactTest-6 score (from 36 to 78 : higher score meaning a worse outcome)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab in people with Cerebral AV Malformation, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Désilles, MD, PhD (01 48 03 64 54, jpdesilles@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches. (time frame: month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.