Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06976671

A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)

Led by Macquarie University, Australia · Updated on 2025-05-16

28

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older at the time of consent
  • Clinical diagnosis of adhesive capsulitis with progressive pain and stiffness lasting more than 2 months but less than 6 months
  • Radiological confirmation showing specific changes in shoulder ligaments or capsule as seen on MRI
  • Normal shoulder X-ray without degenerative changes or previous trauma
  • Ability to provide signed informed consent and comply with study requirements
  • Women of child-bearing potential must agree to use contraception or abstinence during the study and for 120 days after treatment
  • Men must agree to use contraception or abstinence during the study and for 120 days after treatment
  • Women not of child-bearing potential (post-menopausal or permanently sterilized) are eligible
Not Eligible

You will not qualify if you...

  • Previous surgery or treatment with corticosteroids, platelet-rich plasma, or anti-VEGF injections in the affected shoulder
  • History of adhesive capsulitis in the affected shoulder
  • Shoulder trauma unrelated to adhesive capsulitis
  • Imaging signs of calcific tendinopathy
  • Uncontrolled hypertension (blood pressure above 140/100 mmHg)
  • History of cardiovascular disease, recent heart attack, stroke, or transient ischemic attacks
  • Presence of inflammatory arthritis, Parkinson's disease, brain injury, osteoarthritis, glenohumeral bone problems, hypothyroidism, neuromuscular disorders, pre-diabetes, or diabetes
  • Current use of corticosteroids, monoclonal antibodies, or immunosuppressants
  • Planned or prior treatments for the affected shoulder such as injections, nerve blocks, surgery, or other interventions
  • Pain and stiffness lasting less than 2 months or more than 6 months
  • Allergy or hypersensitivity to bevacizumab or its components
  • Active cancer under treatment
  • Pregnancy or breastfeeding
  • Any condition judged by the investigator to affect safety or study participation
  • Employment or family relation to the study site staff
  • Institutionalized individuals or prisoners
  • Unable to provide written informed consent
  • Participation in other clinical trials recently or planned that could affect this study
  • Recent acute illness affecting ability to participate
  • Use of warfarin or other anticoagulants
  • Conditions preventing MRI use, such as severe claustrophobia, morbid obesity, or pacemaker presence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Macquarie University

North Ryde, New South Wales, Australia, 2109

Actively Recruiting

Loading map...

Research Team

S

Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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