Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- ETDRS Visual Acuity
研究概览
简要总结
This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.
详细描述
Background
In previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. It is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. The bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina.
In retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. This is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss.
Objective
To assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rhegmatogenous retinal detachment
- •Central vision affected for less than 72 hours
- •Pseudophakic
- •Age 18 or over
- •Not participating in other clinical trials
- •Willing to attend follow-up visits
- •Written informed consent
- •Exclusion Criteria
- •Narrow angle glaucoma
- •Previous intraocular surgery other than cataract operation
- •Retinal disease
- •Concurrent treatment with MAO inhibitors
- •Pregnancy
- •Malignant arterial hypertension
- •Liver or kidney failure
- •Life-threatening or malignant disease
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days
干预措施: Rasagiline (Drug)
Control
Patients getting perioperative oral treatment with placebo for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
ETDRS Visual Acuity
时间窗: 6 months
次要结局
- Number of patients with side effects(6 months)
- Central retinal thickness(6 months)