Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in clinical activity score (CAS)
研究概览
简要总结
The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.
详细描述
Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral moderate to severe thyroid associated orbitopathy.
- •Clinical Activity score (CAS) ≥
- •Duration of thyroid associated orbitopathy < 2 years
排除标准
- •Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
- •Glaucoma patients or those known to be steroid responders
- •Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
- •Previous orbital or lid surgeries
- •History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
研究组 & 干预措施
Methotrexate
Periocular injections of methotrexate
干预措施: Methotrexate (Drug)
Triamcinolone acetonide
Periocular injections of triamcinolone acetonide
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Change in clinical activity score (CAS)
时间窗: 2 weeks, 1 month, 3 months and 6 months
Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is \>3.
次要结局
- Change in proptosis(2 weeks, 1 month, 3 months and 6 months)
- Change in lid aperture(2 weeks, 1 month, 3 months and 6 months)
- Percentage of overall responders(3 months and 6 months)
研究者
Islam Youssef Swaify
Principal investigator
Cairo University