Study to Assess the Safety and Effectiveness of IBI311 Treatment in Adults with Inactive Moderate to Severe Thyroid-Associated Ophthalmopathy

What this Trial Is About

Thyroid-associated ophthalmopathy TAO is an autoimmune disease linked to thyroid disorders, especially Graves disease, causing complex eye symptoms that can severely affect vision and daily life. This trial studies the effects of IBI311, a fully human antibody targeting the insulin-like growth factor-1 receptor IGF-1R, in patients with inactive moderate to severe TAO. The goal is to evaluate the treatments effectiveness and safety, addressing gaps in current research for this patient group. Participants with inactive TAO will receive eight infusions of IBI311 the first dose at 10 mgkg, followed by seven doses at 20 mgkg, given every three weeks. After the initial four infusions, a three-month observation period occurs before continuing treatment. Another group will only have follow-up visits every six months without receiving the drug. This design allows comparison of treatment effects and monitoring over time. During the study, participants will undergo assessments up to 24 weeks to measure responses in double vision, eye protrusion, and treatment safety including side effects. Quality of life and visual field changes will also be tracked. Safety monitoring includes recording any adverse events throughout the study. The total participation period extends with regular follow-ups, ensuring detailed evaluation of treatment impact and patient well-being.

Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO