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.
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
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)
Single group
Bevacizumab (intra-arterial)
DrugSingle intra-arterial infusion of bevacizumab (reference product or FDA-approved biosimilar) at 2.0, 3.5, or 5.0 mg/kg, delivered via microcatheter into the middle meningeal artery over 5-10 minutes, immediately before MMAE.
Incidence of dose-limiting toxicities
Incidence of dose-limiting toxicities probably or definitely related to IA-BEV
Incidence of SAE's
Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs) probably or definitely related to IA-BEV
Incidence of acute neurological worsening
Incidence of acute neurological worsening (≥2-point NIHSS increase, NIHSS motor sub-score increase, or GCS decline)
Volumetric change in cSDH size
Volumetric change in cSDH size on serial neuroimaging
Rates of surgical rescue, unplanned hospitalization, neurological death, and all-cause mortality
Functional status
As assessed using modified Rankin Scale (mRS)
Distribution of Nakaguchi radiographic subtype and association with treatment response
Dual-energy CT (DECT)-derived membrane biomarkers (volume, maturity grade, iodine leakage) as predictors of outcome
MMA-to-peripheral VEGF concentration ratio as a molecular biomarker of treatment response
Click on the lead sponsor to view all of their trials.
Dheeraj Gandhi
Lead sponsor
University of Maryland, Baltimore
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
