Intravenous bevacizumab for symptomatic brain arteriovenous malformations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 interventional trial gives eligible adults with symptomatic Spetzler-Martin grade III–V cerebral AVMs intravenous bevacizumab or a placebo to test safety and clinical benefit. The rationale is that many AVMs show inflammation and high VEGF-driven angiogenesis, and bevacizumab blocks VEGF signaling. Participants must have disabling symptoms and meet objective severity thresholds (for example MoCA, NIHSS, epilepsy or headache scores) and normal basic labs. Outcomes will include measures of neurological function, symptom scales, and safety monitoring over the treatment and follow-up period at the coordinating center in Paris.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* 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)
* 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

Where it's running

• Hfar
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Study coordinator: Jean-Philippe Désilles, MD, PhD
• Email: jpdesilles@for.paris
• Phone: 01 48 03 64 54

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.