The Effect of Subantimicrobial Dose Doxycycline in Mild Thyroid-Associated Ophthalmopathy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the rate of improvement
研究概览
简要总结
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).
详细描述
Thyroid-Associated Ophthalmopathy is an autoimmune disease that can be treated by corticosteroids and surgery. But they often cause severe side-effects and are usually used for treating moderate-sever and sight-threatening TAO. Wait and see will be the first choice for the patient with mild TAO.
Subantimicrobial dose (SD) doxycycline displays a strong anti-inflammatory and immunomodulatory function, which is independent of its antibiotic properties. Data from clinical trials demonstrated that SD doxycycline was effective in moderating inflammation in a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea and periodontitis.
We propose to test the effect of subantimicrobial dose doxycycline for mild TAO.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Thyroid-associated ophthalmopathy
- •Normal serum free thyroxine and free triiodothyronine concentrations
- •No previous specific therapy for TAO, except for local measures
- •Written informed consent is obtained
排除标准
- •Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females
- •Uncontrolled diabetes or hypertension
- •History of mental / psychiatric disorder
- •Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility)
- •Renal impairment (Urea and Creatinine levels must be within normal range)
- •Tetracycline allergy or intolerance
研究组 & 干预措施
Doxycycline
Tablets Doxycycline 50 mg PO per day for 12 weeks
干预措施: Doxycycline hyclate (Drug)
Placebo
Tablet placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
the rate of improvement
时间窗: 12 weeks
Improvement was defined that at least one item was met in the study eye without deterioration in any item of both eyes: 1. reduction of eyelid aperture by at least 2mm; 2. reduction in exophthalmos by at least 2mm; 3. increase in ocular motility by at least 8 degrees in any duction; 4. increase on either GO-QOL scales by at least 6 points. The higher of the rate of improvement gets, the better the outcome is. The primary outcome ranges from -100% to 100%.
次要结局
- Eyelid aperture(4weeks and 12 weeks)
- Proptosis measured by Hertel instrument(4weeks and 12 weeks)
- Lid retraction(4weeks and 12 weeks)
- Lid lag(4weeks and 12 weeks)
- Clinical Activity Score (CAS)(4weeks and 12 weeks)
- C-OSDI(4weeks and 12 weeks)
- Eye motility(4weeks and 12 weeks)
- Graves' Ophthalmopathy Quality of Life Scale(4weeks and 12 weeks)
- the category of adverse events and the frequency of the occurrence of adverse events(4weeks and 12 weeks)
研究者
Dan Liang
MD
Sun Yat-sen University