Clinical Trial

Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Study acronym: SAFER-MMAE
Not Yet Recruiting Phase 1
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Summary
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.
Trial Details
NCT Number NCT07729098
Lead Sponsor Dheeraj Gandhi
Conditions Chronic Subdural Hematoma
Enrollment 18 participants
Start Date 2027-01-01
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27