Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa and Dry Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes
研究概览
简要总结
The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment and dry age-related macular degeneration (Geographic type) A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
A complete morpho-functional ophthalmological evaluation will be performed in all patients at each control.
详细描述
All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods.
Patients affected by bilateral dry age-related macular degeneration (Geographic type) will be recruited as well.
After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) provided by the Umbilical Cord Bank according to the procedures provided for by the current legislation on blood components for non-transfusion use.
A complete ophthalmological examination will be performed at 1, 3, 6, and 12 months. They will include:
- Anterior segment biomicroscopy
- direct and indirect ophthalmoscopy
- ETDRS visual acuity assessment
- intraocular pressure measurement
- optical coherence tomography (OCT)
- OCT Angiography (OCTA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinal dystrophies with compromised rods (only for RP patients)
- •Visual Field (Manual Goldmann) V / 4e < 30 ° (only for RP patients)
- •Best corrected visual acuity > Light perception
- •Known genotype
- •No or minimal opacity of ocular media
- •No concomitant ocular (eg glaucoma, amblyopia)
- •Dry Age-related Macular Degeneration (Geographic type)
排除标准
- •Age<18 years
- •Pregnancy
- •Previous inflammatory / infectious events involving the eyes
结局指标
主要结局
Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes
时间窗: 3 years
Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images
次要结局
未报告次要终点