A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)
NCT06976671 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-05-16
Summary
This study is intended to test a new treatment for a condition called adhesive capsulitis, also known as frozen shoulder. The treatment being tested is called bevacizumab. Participants will receive a single dose of bevacizumab (50mg, 100mg, 150mg, or 200mg) via injection into their shoulder joint. After the injection, participants will return to site 6 times over the course of a year for safety assessments, questionnaires to track pain levels, and range of movement tests conducted by a physiotherapist.
The main goal of this study is to:
1. Evaluate the safety and effectiveness of bevacizumab when it is injected into the frozen shoulder joint.
2. Determine the maximum dose of bevacizumab that can be given without side effects.
This is an investigator initiated clinical trial sponsored by Macquarie University. There will be a maximum of 28 participants enrolled and the only site involved in recruitment is Macquarie University.
Conditions
- Adhesive Capsulitis
Interventions
- DRUG
-
intra-articular bevacizumab
Sponsors & Collaborators
-
Macquarie University, Australia
lead OTHER
Principal Investigators
-
Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH · Macquarie Unniversity
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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