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BevacizuMAV : Evaluation of the efficacy and safety of anti-angiogenic treatment with intravenous bevacizumab in patients with symptomatic cerebral arteriovenous malformations
EU CTIS ID: 2023-508464-30-00
What this study is testing
Evaluate the 6-month efficacy of IV injections of bevacizumab 5mg/kg every 14 days for 3 months (6 injections) on disabling symptoms in patients with symptomatic cerebral arteriovenous malformations ineligible for interventional therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient over 18 years
- Affiliated or beneficiary of a social security plan
- 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)
You likely can't join if
- Known allergy to bevacizumab or an excipient
- Patient under legal protection
- Pregnant or breast-feeding women
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
- Contraindication to cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating MRI)
- Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breast-feeding woman)
See the full eligibility criteria
- Patient over 18 years
- Affiliated or beneficiary of a social security plan
- 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 prior to inclusion and effective contraception for up to 6 months after the end of treatment
- Fluency in the french language
- Having received informed consent to participate in the study
- Known allergy to bevacizumab or an excipient
- Patient under legal protection
- Pregnant or breast-feeding women
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
- Contraindication to cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating MRI)
- Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breast-feeding woman)
- 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
- Patient with balanced blood pressure on quadritherapy
- Patients with severe coronary artery disease or recent ACS
- Vascular disease (aortic aneurysm, aortic dissection)
- Major surgery, open biopsy or significant traumatic lesion within 4 weeks prior to inclusion, or anticipation of need for major surgery during study period
- 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 within 6 months of inclusion
- Significant unhealed wound, ulcer or bone fracture
- Thrombotic episode within 6 months prior to inclusion
- Atrial fibrillation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.