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NCT06264531: BevacizuMAV
Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations
Phase 2, PHASE3 trial testing Bevacizumab in Cerebral AV Malformation in 54 participants. Currently enrolling.
15 January 2028
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 16 January 2026 |
| Primary completion | 15 January 2028 |
| Estimated completion | 15 January 2029 |
| Sites | 1 location across France |
Drugs / interventions tested
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
- Placebo
Conditions studied
- Cerebral AV Malformation — all drugs for Cerebral AV Malformation →
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):
-
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 -
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 -
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 -
Targeted medical therapies for vascular anomalies.
Borst A. · · 2024 · cited 1× · PMID 39644074 · DOI 10.1182/hematology.2024000599 -
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 -
Vascular malformations: from genetics to therapeutics.
Morin G, Galasso I, Canaud G. · · 2026 · PMID 41272322 · DOI 10.1038/s44321-025-00344-x
Verify or expand the search:
- PubMed search for NCT06264531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06264531 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Ophtalmologique Adolphe de Rothschild
- Last refreshed: 22 January 2026
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