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

Sponsor
Macquarie University, Australia
Study ID
NCT06976671
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adhesive Capsulitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
May 16, 2025
Start date
Sep 10, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intra-articular Bevacizumab
    Bevacizumab administered as a single-dose intra-articular injection at 4 dose levels (50mg, 100mg, 150mg, 200mg)

Primary Outcome Measure

Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis [ Time Frame: 52 Weeks ]

Central Contacts

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