NCT05474950招募中1 期
Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change of cystoid macular edema
研究概览
简要总结
Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.
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 with CME.
- •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.
- •Female that is pregnant, breast-feeding or planning to become pregnant.
- •Participant that is currently using other medications.
研究组 & 干预措施
minocycline
Experimental
干预措施: minocycline (Drug)
结局指标
主要结局
Change of cystoid macular edema
时间窗: At 6 months
Change of CME measured by Optical coherence tomography (OCT)
次要结局
- Change of best corrected visual acuity (BCVA)(At 6 months)
- Change of macular sensitivity(At 6 months)
- Change of retinal vascular leakage(At 6 months)
- Change of macular vessel(At 6 months)
研究者
Dan Liang
Dan Liang, PhD
Sun Yat-sen University
研究点 (1)
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