The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- change of full-field cone electroretinogram amplitude to 30-Hz flashes
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP).
详细描述
Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe treatment are widely applied for it. The worldwide prevalence of RP is estimated to be 1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction are common symptoms. Cone degeneration and associated loss of central vision are typically followed later.
Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly lipophilic molecule and can easily pass through the blood-brain barrier. Several animal experiments and clinical trials have reported that minocycline exert anti-apoptotic, anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.
We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Retinitis Pigmentosa: nyctalopia, visual field constriction and loss of central vision; degeneration of peripheral rod photoreceptor and retinal pigment epithelium cells.
- •Age from 18 to 60 years old.
- •BCVA >20/100(0.2) at least in one eye.
- •Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV at least in one eye.
- •Written informed consent is provided.
排除标准
- •Glucocortticoids or tetracycline were used within 3 months.
- •Vitamin A, DHA and other neurotrophic drugs were used within 3 months.
- •Other ocular diseases or fundus diseases except cataract: glaucoma, diabetic retinopathy, retinal detachment.
- •Tetracycline or minocycline allergy or intolerance.
- •Renal or hepatic insufficiency.
- •History of thyroid neoplasm.
- •History of idiopathic intracranial hypertension.
- •Pregnant or lactating females.
研究组 & 干预措施
Minocycline
Tablets Minocycline 100mg po per day for 12 months
干预措施: Minocycline (Drug)
结局指标
主要结局
change of full-field cone electroretinogram amplitude to 30-Hz flashes
时间窗: 12 months， 24 weeks
increase of full-field cone electroretinogram amplitude to 30-Hz flashes
次要结局
- other ERG indexes(12 months， 24 weeks)
- change of visual field area(12 months， 24 weeks)
- Contrast sensitivity(12 months， 24 weeks)
- central foveal thickness(12 months， 24 weeks)
- Best Corrected Visual Acuity(12 months， 24 weeks)
- color vision(12 months， 24 weeks)
研究者
Dan Liang
Lab of ocular immunology in Zhongshan Ophthalmic Center
Sun Yat-sen University