玻璃体内注射富血小板脐带血血浆治疗干性老年性黄斑变性：再生治疗

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2025-02-04 DOI:10.1016/j.xops.2025.100732

Maria Cristina Savastano MD, PhD , Claudia Fossataro MD, PhD , Alessandro Berni MD , Alfonso Savastano MD, PhD , Valentina Cestrone OA , Federico Giannuzzi MD , Francesco Boselli MD , Matteo Mario Carlà MD , Mattia Cusato MD , Francesco Mottola MD , Riccardo Pirolo MD , Elena D'Agostino OA , Ilaria Biagini OA , Sofia Marcelli OA , Alessandro Gravina MD , Mengxi Shen MD , Clara Rizzo MD , Caterina Giovanna Valentini MD , Maria Bianchi MD , Luciana Teofili MD , Stanislao Rizzo MD

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引用次数: 0

摘要

目的观察玻璃体内注射脐带血富血小板血浆（CB-PRP）对延缓晚期干性年龄相关性黄斑变性（AMD）眼萎缩进展的安全性和有效性。设计随机、对照、前瞻性研究。研究对象年龄为65岁，诊断为双侧地理萎缩的AMD患者。方法1只眼玻璃体内注射CB-PRP 0.05 ml，另1只眼假注射。扫描源OCT血管造影扫描发现，萎缩区域为表面视网膜下色素上皮板（Bruch膜下64-400 μm）上的大脉络膜超透射缺陷（hyperTDs）。主要结果是治疗组和未治疗组眼睛的平方根变换面积测量的平均年增长率。主要观察指标：治疗眼的平均±标准差（SD）超td面积在基线时为3.30±0.99 mm，在CB-PRP （IVI）后为3.49±0.98 mm。未治疗眼的平均根超td面积在基线时为2.96±0.94 mm，在假注射后为3.18±0.94 mm。结果纳入13例患者26只眼。治疗眼的平均±SD最佳矫正视力（BCVA）基线时为48.92±16.33个字母，末次随访时为51.46±12.27个字母。未治疗眼的BCVA基线值为67.69±10.89字母，末次随访时为65.38±10.34字母。平均随访258.46±97.54 d。在两组中，基线和最终BCVA无统计学差异。治疗眼的平均年增长率（平方根）为0.275 mm，未治疗眼的平均年增长率为0.321 mm。治疗组高tds的年化增长率比未治疗组低14.5% （P = 0.007）。无不良事件记录。结论玻璃体内注射CB-PRP可安全有效地延缓AMD的萎缩进程。需要更长的随访和更大的样本量来证实我们的发现，并确定这种新型治疗方案在晚期干性AMD中的最佳治疗方案。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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Intravitreal Injections of Cord Blood Platelet-Rich Plasma in Dry Age-Related Macular Degeneration: Regenerative Therapy

Purpose

Intravitreal injections (IVIs) of umbilical cord blood platelet-rich plasma (CB-PRP) were investigated to assess their safety and efficacy in slowing the progression of atrophy in eyes with late-stage dry age-related macular degeneration (AMD).

Design

Randomized, controlled, prospective study.

Subjects

Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled.

Methods

One eye of each subject received the treatment of intravitreal CB-PRP 0.05 ml, while the fellow eye received a sham injection. Atrophic areas were identified as large choroidal hypertransmission defects (hyperTDs) on en face subretinal pigment epithelium slabs (64–400 μm beneath Bruch's membrane) obtained 0.321 from swept-source OCT angiography scans. The main outcome was the mean annualized growth rate of the square root transformed area measurements in both treated and nontreated eyes.

Main Outcome Measures

The mean ± standard deviation (SD) square root hyperTD area in the treated eyes was 3.30 ± 0.99 mm at baseline and 3.49 ± 0.98 mm after CB-PRP (IVI). In nontreated eyes, the mean square root hyperTD area was 2.96 ± 0.94 mm at baseline and 3.18 ± 0.94 mm after sham injections.

Results

Twenty-six eyes of 13 patients were included. In treated eyes, the mean ± SD best-corrected visual acuity (BCVA) was 48.92 ± 16.33 letters at baseline and 51.46 ± 12.27 letters at last follow-up. In untreated eyes, BCVA was 67.69 ± 10.89 letters at baseline and 65.38 ± 10.34 letters at last follow-up. The mean follow-up was 258.46 ± 97.54 days. In both groups, no statistically significant difference was observed between the baseline and final BCVA. For treated eyes, the mean annualized growth rate (square root) was 0.275 mm and for nontreated eyes it was 0.321 mm. The annualized growth rate of the hyperTDs in treated eyes was 14.5% lower than that in nontreated eyes (P = 0.007). No adverse events were recorded.

Conclusions

These preliminary data suggest that intravitreal CB-PRP injections might be safe and effective in slowing the progression of atrophy in AMD. Extended follow-up and larger sample sizes are needed to confirm our findings and determine the optimal treatment regimen for this novel treatment option in late-stage dry AMD.