A Phase II Proof-of-concept Study Evaluating the Safety and Efficacy of Bevacizumab in the Treatment of Adhesive Capsulitis
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.
⁃ IC1. Over 18 years of age (inclusive) at the time of signing informed consent
⁃ IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
• Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
• Either thickening or signal hyperintensity associated with coracohumeral ligament, axillary pouch, or rotator interval joint capsule OR obliteration of the subcoracoid fat triangle as confirmed by radiological examination (magnetic resonance imaging); and,
• Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma.
⁃ IC3. Capable of giving signed informed consent as described in Section 14 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
⁃ IC4. Participants of child-bearing potential are eligible to participate if they agree to the following during the study intervention period and for a minimum of 120 days after the study intervention is administered:
• Female participants must not be pregnant or breastfeeding AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR engage in an adequate method of contraception (i.e., the oral contraceptive pill, intrauterine device, or other)
• Male participants must refrain from donating sperm AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR must agree to use an adequate method of contraception/barrier method (i.e. condom and/or heterosexual partner engaging in an adequate method of contraception as previously described)
⁃ IC5. Participants who are not of child-bearing potential, defined as at least one or more of the following criteria, are eligible to participate in the study
• Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
• Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)