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

Launched by MACQUARIE UNIVERSITY, AUSTRALIA · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adhesive capsulitis, commonly known as frozen shoulder. The treatment being tested is called bevacizumab, which will be injected directly into the shoulder joint. Participants will receive one of four different doses of this medication and will need to visit the clinic six times over the following year to check on their safety, track their pain levels, and assess how well they can move their shoulder.

To be eligible for this study, participants need to be at least 18 years old and have a clinical diagnosis of frozen shoulder that has been causing pain and stiffness for more than two months but less than six months. Other criteria include having a normal shoulder X-ray and being able to provide informed consent. During the trial, participants can expect close monitoring by healthcare professionals and may help researchers learn more about the effectiveness and safety of this new treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • IC1. Over 18 years of age (inclusive) at the time of signing informed consent
• IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
• • 1. Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
• • 2. 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,
• • 3. 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:
• • 1. 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)
• • 2. 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
• • 1. Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
• • 2. Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)
• Exclusion Criteria:
• • EC1. History of previous surgery or treatment with corticosteroid prior to screening, platelet-rich plasma, or anti-VEGF injections in the ipsilateral shoulder
• • EC2. History of adhesive capsulitis in ipsilateral shoulder
• • EC3. Presence of trauma in the affected shoulder unrelated to adhesive capsulitis
• • EC4 Advanced imaging features associated with calcific tendinopathy
• • EC5. Presence of uncontrolled hypertension (defined as systolic pressure \> 140mmHg and diastolic pressure \> 100mmHg)
• • EC6. Any medical history of cardiovascular disease, uncontrolled ischemic heart disease, acute myocardial infarction within 12 months of study entry, or any history of intracranial hemorrhage, stroke or a transient ischaemic attacks at any time
• • EC7. Presence of inflammatory arthritis (such as but not limited to: systemic lupus erythematosus, rheumatoid arthritis, reactive arthritis, etc.), Parkinson's disease, brain injury, osteoarthritis, bony glenohumeral pathology, hypothyroidism, neuromuscular disorders, or pre-diabetes or diabetes mellitus (defined by fasting glucose ≥7mmol/L and Hba1c ≥ 5.7%)
• • EC8. Participants currently taking corticosteroids, monoclonal antibody therapy, or other immunosuppressants which are deemed to impact the study endpoints
• EC9. Planning to or have received treatment for the affected shoulder at any time during the study or prior to the study included but not limited to:
• • 1. Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities
• • 2. Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography
• • 3. Surgical intervention
• • EC10. Progressive pain and stiffness in the affected shoulder that is for a period less than 2 months or greater than 6 months
• • EC11. Hypersensitivity to the study intervention, including any constituents thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• • EC12. Any active malignancy under treatment
• • EC13. Women who are pregnant and/or breastfeeding, or who plan to be pregnant in the following six months after study intervention
• • EC14. Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions that might affect their safety or ability to complete the protocol or that may confound the efficacy or safety results of the trial
• • EC15. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6)
• • EC16. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised
• • EC17. Participants unable to provide written informed consent
• • EC18. Participants who have participated in other clinical trial within 1 month, have participated in another study within 6 months from the date of selection, or have planned for participation in another trial during the follow up period of this trial which is deemed by the Investigator to impact the planned study endpoints of this study
• • EC19. Acute illness within the 30 days prior to V1 that, in the opinion of the Investigator, affects the participant's ability to participate in the study.
• • EC20. Participants currently taking warfarin or any other anti-coagulation therapies.
• • EC21.Participants deemed with any condition which would preclude their use for study-related magnetic resonance imaging procedures, including but not limited to: morbid obesity, severe claustrophobia, and/or permanent pacemaker).