Actively Recruiting
Evaluating the Safety and Efficacy of Bevacizumab Injection for Adhesive Capsulitis (Frozen Shoulder)
Led by Macquarie University, Australia · Updated on 2025-05-16
28
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a condition called adhesive capsulitis, also known as frozen shoulder. The study aims to evaluate the safety and effects of bevacizumab, a drug injected directly into the shoulder joint, and to determine the highest dose that can be given without causing serious side effects. This phase II trial is led by Macquarie University and will include up to 28 adults diagnosed with frozen shoulder. Participants will receive a single injection of bevacizumab in one of four doses: 50mg, 100mg, 150mg, or 200mg. The trial uses a dose-escalation design, starting with low doses and increasing only if safety allows. After the injection, participants will be monitored closely for dose-limiting toxicities before moving to higher doses or stopping if side effects occur. The highest dose planned is 200mg, with up to 10 participants in this group unless safety concerns arise. Over the next year, participants will visit the study site six times for safety checks, pain questionnaires, and movement tests led by a physiotherapist. Researchers will assess the safety of bevacizumab over 52 weeks and identify the maximum tolerated dose within one week after injection. They will also track how well the treatment works to reduce symptoms of frozen shoulder during this period.
CONDITIONS
Brief Title
A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of adhesive capsulitis with symptoms lasting more than 2 months but less than 6 months
- Radiological evidence supporting diagnosis without signs of shoulder joint degeneration or previous trauma
- Ability to provide informed consent
- Women of child-bearing potential must agree to pregnancy prevention during and for 120 days after treatment
- Men must agree to use contraception and avoid sperm donation during and 120 days after treatment
- Post-menopausal women or those with permanent sterilisation are eligible
You will not qualify if you...
- Previous surgery or corticosteroid, platelet-rich plasma, or anti-VEGF treatment in the affected shoulder
- History of adhesive capsulitis in the affected shoulder
- Shoulder trauma unrelated to adhesive capsulitis
- Calcific tendinopathy seen on imaging
- Uncontrolled high blood pressure
- Cardiovascular diseases, recent heart attack, stroke, or brain injury
- Inflammatory arthritis, Parkinson's disease, brain injury, osteoarthritis, bony shoulder pathology, hypothyroidism, neuromuscular disorders, pre-diabetes or diabetes
- Use of corticosteroids, monoclonal antibodies, or immunosuppressants affecting study outcomes
- Planned or prior shoulder treatments including injections or surgery during the study
- Symptom duration less than 2 months or more than 6 months
- Allergy or hypersensitivity to study drug
- Active cancer under treatment
- Pregnancy or breastfeeding or plans to become pregnant within 6 months post-treatment
- Conditions affecting safety or study completion as judged by investigator
- Employees or family of study site staff
- Institutionalized individuals or prisoners
- Unable to provide informed consent
- Recent participation in other clinical trials affecting this study
- Acute illness interfering with participation
- Use of warfarin or other anticoagulants
- Conditions preventing MRI procedures such as severe claustrophobia or pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week or until dose escalation is determined
Participants receive a single-dose intra-articular injection of bevacizumab at escalating dose levels to determine safety and efficacy.
1 treatment visit and safety evaluation at 1 week after treatment
Duration - 52 weeks
Participants are monitored for safety and efficacy outcomes over a 52-week period after treatment.
Periodic visits during 52 weeks of follow-up
Trial Site Locations
Total: 1 location
1
Macquarie University
North Ryde, New South Wales, Australia, 2109
Actively Recruiting
Research Team
S
Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here