Claudia Fossataro, Maria Cristina Savastano, Mattia Cusato, Valentina Cestrone, Francesco Mottola, Lorenzo Hu, Giorgia Campaniello, Gianmarco Oreste, Federico Giannuzzi, Emanuele Maiola, Giulia Mastropietro, Alfonso Savastano, Caterina Giovanna Valentini, Claudio Pellegrino, Luciana Teofili, Stanislao Rizzo
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引用次数: 0
Abstract
Background: Dry age-related macular degeneration currently lacks effective treatments for geographic atrophy. Cord blood platelet-rich (CB-PRP) plasma intravitreal injections are a novel therapy under investigation with promising ad interim results.
Objectives: To describe the safety profile of cord blood platelet-rich plasma intravitreal injections (IVIs) in dry age-related macular degeneration (AMD) patients.
Design: This prospective, randomized, sham-controlled, open-label experimental trial evaluated the safety of repeated intravitreal CB-PRP injections.
Methods: The study, conducted from January 2023 to January 2025, investigated the safety and efficacy of CB-PRP IVIs to slow down the progression of geographic atrophy (GA). One eye of each patient was randomly assigned to the monthly, every other month, or every 3 months arm and received 0.05 mL CB-PRP, while the other eye underwent only a sham injection. Complete ophthalmological evaluations were performed at baseline, 3-, 6-, 12-, 18-, and 24-month follow-ups. In addition, slit-lamp and fundus examinations were performed the day after the injection to exclude any adverse effect.
Results: In a total of 328 intravitreal injections, vitreous opacities were observed in the absence of other signs of infection or inflammation only in three cases. All of them showed progressive improvement without treatment, and complete recovery was observed within 2 weeks.
Conclusion: Although the pathogenesis of the detected vitreous thickening was not completely clear, the most likely hypothesis was the coexistence of a slightly lower temperature of the CB-PRP sample and individual factors. This mild adverse event occurred only once in each patient involved, with no recurrence during subsequent intravitreal injections. The occurrence of this self-limiting finding after CB-PRP IVIs has not invalidated the safety profile of the procedure.
背景:干性年龄相关性黄斑变性目前缺乏有效的治疗地理萎缩。富血小板脐带血(CB-PRP)血浆玻璃体内注射是一种正在研究中的新疗法,具有良好的中期结果。目的:描述富血小板脐带血血浆玻璃体内注射(IVIs)治疗干性年龄相关性黄斑变性(AMD)患者的安全性。设计:这项前瞻性、随机、假对照、开放标签的试验评估了反复玻璃体内注射CB-PRP的安全性。方法:本研究于2023年1月至2025年1月进行,研究CB-PRP IVIs延缓地理萎缩(GA)进展的安全性和有效性。每个患者的一只眼睛随机分配到每月、每隔一个月或每3个月的组,接受0.05 mL CB-PRP,而另一只眼睛只接受假注射。在基线、3个月、6个月、12个月、18个月和24个月随访时进行完整的眼科评估。此外,注射后第二天进行裂隙灯和眼底检查,以排除任何不良反应。结果:在328例玻璃体内注射中,只有3例在没有其他感染或炎症体征的情况下观察到玻璃体混浊。所有患者均在未经治疗的情况下逐渐好转,2周内完全康复。结论:虽然检测到的玻璃体增厚的发病机制尚不完全清楚,但最可能的假设是CB-PRP样品温度略低与个体因素共存。这种轻微的不良事件在每个患者中只发生一次,在随后的玻璃体内注射中没有复发。在CB-PRP静脉注射后出现这种自限性发现并没有使该手术的安全性失效。