Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma: Multicenter 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
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).
详细描述
Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated.
The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.
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
- Single (Participant)
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.
结局指标
主要结局
Autofluorescence atrophy area changes in treated eyes compared with sham group
时间窗: 24 months
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
- Outer retinal atrophy (iRORA)(24 months)
- ETDRS visual acuity(24 months)
- Stabilization of the atrophy region of the EPR(24 months)
- Mean increase in retinal volumetrics(24 months)
- Retinography of the ocular fundus(24 months)
- Mean increase in ONL thickness and retinal volumetrics(24 months)
- Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)(24 months)
研究者
Savastano Maria Cristina
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS