Evaluation of the Efficacy and Safety of Intravenous Methylprednisolone Pulse Therapy in Patients with Active, Moderate to Severe Thyroid Eye Disease: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- High patient tolerance and compliance with the 3-weekly IV regimen due to fewer hospital visits and manageable side effects.
研究概览
简要总结
Thyroid Eye Diseaseis an autoimmune inflammatory disorder that can cause proptosis, diplopia, and vision-threatening complications. High-dose corticosteroids are the mainstay of treatment, with weekly intravenous methylprednisolone pulses recommended by EUGOGO guidelines as first-line therapy. However, weekly protocols require frequent hospital visits and can increase healthcare burden and patient dropout rates. This study aims to evaluate the efficacy and safety of a 3-weekly IVMP pulse regimen which is, 1 g IVMP daily for 3 days as induction, followed by 500 mg IVMP every 3 weeks for 5 cycles in patients with active, moderate-to-severe TED. Outcomes will be assessed using Clinical Activity Scoreand VISA scoring at baseline and at each follow-up visit to monitor improvement in inflammation, proptosis, strabismus, and visual function. The study expects to demonstrate comparable efficacy to weekly regimens, improved patient compliance, and a favorable safety profile, potentially offering a more convenient and resource-efficient alternative for TED management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosis of moderate-to-severe active TED with CAS more than 3, with normal renal and liver function test and written consent form taken.
排除标准
- •Sight threatening TED, Previous orbital radiotherapy or decompression surgery, History of steroid intolerance or contraindication, Uncontrolled systemic illnesses, Pregnancy or lactation.
结局指标
主要结局
High patient tolerance and compliance with the 3-weekly IV regimen due to fewer hospital visits and manageable side effects.
时间窗: 12 months
Reduction in Clinical Activity Score (CAS) and VISA score indicating decreased orbital inflammation and disease activity.
时间窗: 12 months
次要结局
未报告次要终点
研究者
Dr MEGHA YOGESH JANGLE
Aravind Eye Hospital, Poonamallee
