Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- fluorescence fundus angiography
研究概览
简要总结
The purpose of this study is to investigate the role of intravitreal injection of anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of ophthalmological neovascular diseases, in order to find a new strategy of treatment for ophthalmological neovascular diseases
详细描述
Ophthalmological neovascular disease is one of the major causes of blindness in ocular diseases. Up to now, the major treatment strategies include: anti-VEGF therapy, laser therapy and surgery. Clinical treatment have revealed that intravitreal injection of anti-VEGF can effectively restrain neovascularization. Nevertheless, it requires repeated injections, may result in various complications, and may be ineffective in some patients. Therefore, it is necessary to find out other targets which causes retinal neovascularization, in order to find more effective treatments for patients who fail to respond to anti-VEGF therapy. Previous researches have shown that herb monomer (ACM-1) was effective in inhibiting leakage of retinal vessels and neovascularization. So in this study, patients with ophthalmological neovascular diseases will be treated with intravitreal injection of ACM-1, in order to investigate the role of intravitreal injection of ACM-1 therapy in prevention and control of ophthalmological neovascular diseases.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range from 18 to 75 years old
- •without light perception (NLP)
- •A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball
- •The best corrected visual acuity of the contralateral eye is better than 0.05
- •Follow-up for more than six months
- •Volunteer for this project and sign the informed consent
排除标准
- •The best corrected visual acuity of the contralateral eye is lower than 0.05
- •Severe systemic disease or other surgical contraindication
- •history of antiangiogenic therapy within one month
- •Ocular neovascularization was caused by other reasons,such as endophthalmitis
- •history of joining in drug clinical trial within one month(except for vitamins and minerals)
- •pre-menopausal women who do not use birth control
- •people are currently being treated for systemic infections
- •Allergic to fluorescein
- •hypertension(SBP is higher than 140mmHg)
- •hepatic renal dysfunction
- •History of drug abuse or alcoholism
- •other situation which will impede the clinical trial, as such depressive disorder
- •the compliance is too poor to finish the clinical trial
研究组 & 干预措施
ACM-1 team
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
干预措施: ACM-1 (Drug)
结局指标
主要结局
fluorescence fundus angiography
时间窗: 6 months after treatment
次要结局
- intra-ocular pressure(6 months after treatment)
- ocular inflammatory response(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
- morphological changes of the anterior segment(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
- optical coherence tomography(6 months after treatment)
- Retinal Oximetry(6 months after treatment)
- Corneal Endothelium Cell Counter(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
- morphological changes of the posterior segment(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
- blood pressure(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
- adverse event(at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment)
研究者
Qianying Gao
professor
Sun Yat-sen University