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临床试验/CTRI/2025/09/095289
CTRI/2025/09/095289尚未招募不适用

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

Aravind eye hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月14日最近更新:

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

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr MEGHA YOGESH JANGLE

Aravind Eye Hospital, Poonamallee

研究点 (1)

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