Neuroprotection and Neuroenhancement in a Model of Optic Nerve Neurodegeneration (Non Arteritic Ischemic Optic Neuropathy): Study of Morpho-functional Changes Related to Treatment With Citicoline Oral Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change From Baseline in Visual Acuity at 9 Month
研究概览
简要总结
The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).
详细描述
The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar controls
Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute visual reduction episode from NAION occurring for more than 6 months
- •Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2
- •Visual acuity not less than 1/10
- •Having suspended any potential neuroprotective therapies (e.g., Coenzyme Q10) for at least 6 months.
排除标准
- •Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- •Cataract or maculopathy
- •Known hypersensitivity to the study product
- •Positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement
- •Pregnant or nursing women, or women of potential childbearing age not using adequate contraception.
- •Diabetes, SLE, rheumatoid arthritis, mixed connective tissue disease
结局指标
主要结局
Change From Baseline in Visual Acuity at 9 Month
时间窗: 9 months vs baseline
Increase of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR)
次要结局
- Change From Baseline in Retinal Ganglion Cells Function at 9 Month(9 months vs Baseline)
- Change From Baseline in Optic Nerve Function at 9 Months(9 months vs baseline)
- Change From Baseline in Optic Nerve Morphology at 9 Months(9 months vs baseline)
- Change From Baseline in Visual Field Defects at 9 Months(9 months vs baseline)