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

NCT07729098 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Chronic Subdural Hematoma

Interventions

DRUG

Bevacizumab (intra-arterial)

Single 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.

Sponsors & Collaborators

  • Dheeraj Gandhi

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-01-01
Completion
2029-06-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729098 on ClinicalTrials.gov