Long-term Morphological and Functional Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy
研究概览
简要总结
Citicoline (cytidine-5'-diphosphocholine) is an essential precursor in the synthesis of phosphatidylcholine, a component of cell membranes. Several experimental in vitro and in vivo studies have suggested that citicoline plays a neuroprotective role.
A recent clinical study has shown that treatment with topical citicoline induces, after 60 days of therapy, a significant improvement in the ganglion cell function .In addition topical citicoline has been demonstrated in vivo a neuroprotective effect in preventing diabetic retinopathy .
The Investigators want to evaluate if citicoline may reduce the progression of retinal damage in patients with mild diabetic retinopathy.
详细描述
The investigators evaluated patients with mild signs of diabetic retinopathy (DR) treated with eye-drop solution with citicoline ( OMk2 ophthalmic solution).
All patients was randomized in two groups (10:10), one receiving topical administration of OMk2 ophthalmic solution for 36 months and one group receiving only the excipients of OMk2 (placebo).
Omk2 ophthalmic solution and the placebo will be used for 36 months three times/day.
They will undergo a complete ocular examination at baseline and at 6-, 12-, 18-, 24-, 30- and 36- months after treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 DM
- •Diagnosis of mild Diabetic rethnopathy (DR)
- •Retinal sensitivity impairment evaluated by means of frequency doubling technology (Matrix FDT) with a mean deviation (MD) p value <5% or with two locations with p <5% and one location with p<1% in the total or pattern deviation plots.
排除标准
- •Hyperopia higher than +5 diopter (D)
- •myopia higher than -8 D
- •astigmatism higher than 2 D
- •Visual acuity below 20/25
- •significant media opacity
- •previous ocular surgery
- •previous diagnosis of glaucoma
- •retinal disease other than mild diabetic retinopathy
- •patients with any ocular disease
- •systemic disease other than diabetes
- •Any signs of diabetic retinopathy more advanced than mild as coded by ICDRSS (e.g. macular edema or any sign of proliferative DR)
研究组 & 干预措施
OMK2 group
Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day
干预措施: OMK2 group (Other)
Placebo group
Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day
干预措施: Placebo group (Other)
结局指标
主要结局
Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy
时间窗: Functional retinal changes at 36 months
To evaluate functional retinal parameters : retinal sensitivity by Humphrey Matrix and contrast sensitivity function by Pelli Robson in patients with diabetic retinopathy
次要结局
- Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy(Morphological retinal changes at 36 months)
研究者
Mariacristina Parravano
Head of Retina Unit
Fondazione G.B. Bietti, IRCCS