The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change of macular sensitivity
研究概览
简要总结
Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
- •Participant aged from 18-60 years old.
- •Participant that signed the informed consent document and is able to complete the following visits.
排除标准
- •Participant is allergy to minocycline or tetracyclines.
- •Participant has no contraindications of minocycline or tetracyclines.
- •Participant has an abnormal function of liver, heart, kidney and thyroid.
- •Participant is using glucocorticoids, immunosuppressants or biologics.
- •Female that is pregnant, breast-feeding or planning to become pregnant.
- •Participant that is currently using other medications for other diseases.
研究组 & 干预措施
minocycline
minocycline capsule 100mg per day orally
干预措施: minocycline (Drug)
结局指标
主要结局
Change of macular sensitivity
时间窗: At 6 and 12 months
Change of macular sensitivity measured by MAIA
Change of BCVA
时间窗: At 6 and 12 months
Change of BCVA measured by ETDRS
Change of Visual field
时间窗: At 6 and 12 months
Change of Visual field measured by HVF 30-2 visual field testing
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses
时间窗: At 6 and 12 months
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing
次要结局
- Change of QoL questionaire(At 6 and 12 months)
- Change of macular vessel(At 6 and 12 months)
- Change of Contrast Sensitivity(At 6 and 12 months)
- Change of Color Visual(At 6 and 12 months)
- Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of Ocular and Non-ocular Adverse Events(At 6 and 12 months)
研究者
Dan Liang
Dan Liang, PhD
Sun Yat-sen University