NCT04422743终止不适用
Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study
Fondazione IRCCS Policlinico San Matteo di Pavia8 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
研究概览
简要总结
the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
详细描述
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 40 and 75 years;
- •diagnosis of primary OAG (POAG) from, at least, 3 years;
- •visual acuity > 0.7 (7/10) decimals;
- •refractive error < 5 D (spheric) and < 2D (toric);
- •transparent diopter means (cornea and lens);
- •controlled IOP (<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed);
- •stable IOP<18 mmHg in the last 2 years;
- •stable and unchanged topical therapy in the last 6 months;
- •stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);
- •at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years;
- •early to moderate visual field defect (MD <12 dB);
- •electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;
- •written consent to participate to study procedures and data utilization in an anonymous form
排除标准
- •ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
- •congenital glaucoma; secondary glaucoma; normal tension glaucoma;
- •history of recurrent uveitis/scleritis/herpes infection;
- •pregnancy and breastfeeding;
- •contraindication to Citicoline and/or Homotaurine
- •contraindication to beta-blockers and prostaglandine analogues
- •topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide)
- •topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment
- •systemic therapies affecting patients' performance in visual field examination (sedatives);
- •glaucomatous scotomas within 10 degree from fixation
- •any condition limiting the patient's ability to participate in the study;
- •other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;
- •other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;
- •cerebral ischemia in the last 2 years
- •any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial
- •any previous filtering and/or retinal surgery;
- •cataract surgery in the last 6 months;
- •any previous laser treatment for glaucoma in the last 5 years
结局指标
主要结局
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
时间窗: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in amplitude (microVolt)
次要结局
- to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life(4 months of therapy 2 months of wash out 4 months without adding therapy)
- To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity(4 months of therapy 2 months of wash out 4 months without adding therapy)
- to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field(4 months of therapy 2 months of wash out 4 months without adding therapy)
研究者
Gemma Caterina Maria Rossi
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (8)
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