Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
Starting soon · Phase 1
Conditions studied: Chronic Subdural Hematoma
In brief
This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg/kg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.
Key facts
- Study ID
- NCT07729098
- Run by
- Dheeraj Gandhi
- People needed
- 18
- Starts
- 2027-01-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-85 years
- Scheduled to undergo MMAE as standard of care for cSDH, no concurrent surgical evacuation planned (prior surgery for the target cSDH allowed if ≥14 days elapsed)
- Radiographically confirmed cSDH meeting specified unilateral/bilateral density criteria
- cSDH volume 20-100 cc
- Midline shift <8 mm
- Markwalder Grade 1 or 2
- Subject or LAR able to provide written informed consent
You may not qualify if…
- Requires immediate/urgent surgical evacuation
- Prior large craniotomy, membranectomy, or MMAE for the current target cSDH
- Life expectancy <1 year
- Uncontrolled bleeding disorder (INR >1.7, aPTT >35s, platelets <100,000/μL)
- Concurrent intracranial hemorrhage outside the target subdural space
- Persistent neurological deficit from another acute/chronic neurological condition
- Pregnancy or lactation
- Known/suspected intracranial neoplasm or mass lesion
- Active alcohol/substance use disorder within 12 months
- Baseline mRS ≥3
- Uncontrolled severe hypertension (SBP >220 or DBP >120, or IV antihypertensive need within 24h pre-procedure)
- Thromboembolic event within 6 months (DVT, PE, TIA, stroke)
- Contraindication to VTE prophylaxis
- eGFR <60 mL/min/1.73m² or acute kidney injury at screening
- Known hypersensitivity to bevacizumab or its components
Full record on ClinicalTrials.gov
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