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NCT06264531: BevacizuMAV

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

Recruiting now Phase 2, PHASE3 Last updated 22 January 2026
What this trial tests

Phase 2, PHASE3 trial testing Bevacizumab in Cerebral AV Malformation in 54 participants. Currently enrolling.

Timeline
16 January 2026
Primary endpoint
15 January 2028
15 January 2029

Quick facts

Lead sponsorFondation Ophtalmologique Adolphe de Rothschild
PhasePhase 2, PHASE3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment54
Start date16 January 2026
Primary completion15 January 2028
Estimated completion15 January 2029
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

18 and older, any sex, with Cerebral AV Malformation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pathophysiology in Brain Arteriovenous Malformations: Focus on Endothelial Dysfunctions and Endothelial-to-Mesenchymal Transition.
    Jeong JY, Bafor AE, Freeman BH, Chen PR, et al · · 2024 · cited 6× · PMID 39200259 · DOI 10.3390/biomedicines12081795
  2. Extracranial arteriovenous malformations: towards etiology-based therapeutic management.
    Coulie J, Seront E, Vikkula M, Boon LM. · · 2025 · cited 5× · PMID 40091828 · DOI 10.1172/jci172837
  3. Advances in sporadic brain arteriovenous malformations: Novel genetic insights, innovative animal models and emerging therapeutic approaches.
    Ueki Y, Naylor RM, Ghozy SA, Thirupathi K, et al · · 2025 · cited 2× · PMID 39948029 · DOI 10.1177/0271678x251319913
  4. Targeted medical therapies for vascular anomalies.
    Borst A. · · 2024 · cited 1× · PMID 39644074 · DOI 10.1182/hematology.2024000599
  5. Advances in the Genetics and Molecular Biology of Brain Arteriovenous Malformations.
    Tsuchiya T, Miyawaki S, Ono H, Hongo H, et al · · 2026 · PMID 41999461 · DOI 10.1007/s12975-026-01436-7
  6. Vascular malformations: from genetics to therapeutics.
    Morin G, Galasso I, Canaud G. · · 2026 · PMID 41272322 · DOI 10.1038/s44321-025-00344-x

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