Evaluating Safety and Effectiveness of Bevacizumab Injection for Frozen Shoulder in Adults A Phase II Dose-Ranging Study at Macquarie University

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.

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