Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
研究概览
简要总结
The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD)
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Bilateral dry-AMD
- •ETDRS-corrected visual acuity between (or equal to) 1/10 and 4/10
- •No concomitant ocular pathology (e.g., Glaucoma, amblyopia) or systemic pathology that would result in a BIAS for primary goal assessment
- •Signature of informed consent
排除标准
- •Age < 65 years
- •Pregnancy
- •Previous inflammatory/infectious events involving the eyes
- •Eye trauma, diabetes, or disease potentially damaging to the visual system, even in the absence of impairment at the time of intake
- •Previous intravitreal treatments.
- •Refusal to sign informed consent.
研究组 & 干预措施
Monthly injection
The patients will recive 12 intravitreal injections in one eye and 12 sham injections in the other eye each month
干预措施: Intravitreal injection of CB-PRP (Procedure)
Bimonthly injection
The patients will receive 6 intravitreal injections in one eye and 6 sham injections in the other eye each two months
干预措施: Intravitreal injection of CB-PRP (Procedure)
Quarterly injection
The patients will receive 4 intravitreal injections in one eye and 4 sham injections in the other eye each three months
干预措施: Intravitreal injection of CB-PRP (Procedure)
结局指标
主要结局
Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
时间窗: 1 year
Stabilization of the enlargement of the hyperfluorescent area (atrophy enhancement) or at most a maximum increase of not more than 20% from the baseline
Autofluorescence atrophy area changes in treated eyes compared with sham group
时间窗: 1 year
Stabilization of enlargement of hypoautofluorescent area (atrophy) or at most a maximum increase of no more than 20% compared with baseline in treated subjects compared with placebo group from baseline until follow-ups
次要结局
- Mean increase in retinal volumetrics(1 year)
- ETDRS visual acuity(1 year)
- Mean increase in ONL thickness and retinal volumetrics(1 year)
- Stabilization of the atrophy region of the EPR(1 year)
- Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)(1 year)
- Retinography of the ocular fundus(1 year)
- Outer retinal atrophy (iRORA)(1 year)