■评估视网膜下注射脐带血富血小板血浆(CB-PRP)的安全性及其在干性年龄相关性黄斑变性(d-AMD)相关的地图状萎缩(GA)中的可能作用。
■干预性,开放标签研究于2021年1月开始,并在12个月时进行随访(Si.绳索研究)。这项研究是单中心的,非随机化,在罗马进行的序贯分配临床试验,意大利,在阿戈斯蒂诺·盖梅利大学基金会IRCCS(ClinicalTrials.govNCT04636853)。
■纳入13例(26只眼)双侧d-AMD相关性GA患者。每位患者(晚期GA)的一只眼睛接受CB-PRP治疗,对方的眼睛被认为是控制。所有患者均在12个月时参加随访。
■所有13只眼睛都接受了23号(G)玻璃体切除术和使用41号针头的视网膜下注射CB-PRP。
■带有ETDRS字母的最佳矫正视力(BCVA),使用OCT测量黄斑中心厚度,在基线时评估面部OCT图像上测量的萎缩面积,1、3、6和12个月。
■治疗组的BCVA在基线时为34.46±20.8ETDRS,1个月时40.84±20.52,3个月时40.07±20.34,6个月时39.38±19.84,12个月时35.84±18.38。在未经治疗的组中,基线时BCVA为53±21.1ETDRS字母,1个月时51.54±20.99,3个月时46.62±19.47,6个月时46.85±18.58,12个月时为43.92±17.97(双向方差分析:眼睛或时间的治疗相互作用,P=0.084)。在12个月时,中央黄斑厚度没有显着差异(P=0.97)。12个月时,接受治疗的眼睛和其他眼睛的萎缩地理区域趋于增加(P<0.0001)。没有炎症反应,眼内炎,视网膜脱离,葡萄膜炎,随访期间观察到视网膜下注射CB-PRP引起的其他并发症。
■视网膜下注射CB-PRP可以安全地用于GA形式的d-AMD。尽管安全,更多的患者,可能是一种新的管理方式,需要了解CB-PRP是否可以在GA治疗中发挥作用。
■专有或商业披露可在本文末尾的脚注和披露中找到。
UNASSIGNED: To evaluate the safety of subretinal injection of cord blood platelet-rich plasma (CB-PRP) and its possible effect in eyes affected by geographic atrophy (GA) associated with dry age-related macular degeneration (d-AMD).
UNASSIGNED: Interventional, open-label study started in January 2021 with follow-up at 12 months (the Si.Cord Study). This study was a single-center, nonrandomized, sequential-assigned clinical trial conducted in Rome, Italy, at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (ClinicalTrials.gov NCT04636853).
UNASSIGNED: Thirteen patients (26 eyes) with bilateral d-AMD-related GA were enrolled. One eye from each patient (with more advanced GA) underwent CB-PRP treatment, and the fellow eye was considered the control. All patients participated in follow-up at 12 months.
UNASSIGNED: All 13 eyes received 23-gauge (G) vitrectomy and subretinal injection of CB-PRP using a 41-gauge needle.
UNASSIGNED: Best-corrected visual acuity (BCVA) with ETDRS letters, central macular thickness using OCT, and atrophic area measured on en face OCT images were assessed at baseline, 1, 3, 6, and 12 months.
UNASSIGNED: The BCVA in the treated group was 34.46 ± 20.8 ETDRS at baseline, 40.84 ± 20.52 at 1 month, 40.07 ± 20.34 at 3 months, 39.38 ± 19.84 at 6 months, and 35.84 ± 18.38 at 12 months. In the untreated group, the BCVA was 53 ± 21.1 ETDRS letters at baseline, 51.54 ± 20.99 at 1 month, 46.62 ± 19.47 at 3 months, 46.85 ± 18.58 at 6 months, and 43.92 ± 17.97 at 12 months (2-way analysis of variance: interaction of treatment by eye or time, P = 0.084). Central macular thickness did not show a significant intereye difference at 12 months (P = 0.97). The atrophic geographic areas tended to increase in both treated and fellow eyes at 12 months (P < 0.0001). No inflammatory reaction, endophthalmitis, retinal detachment, uveitis, or other complications due to the subretinal injection of CB-PRP were observed during the follow-up.
UNASSIGNED: Subretinal injection of CB-PRP could be safely used for d-AMD in its GA form. Despite its safety, a larger cohort of patients, and probably a new way of administration, will be needed to understand whether the CB-PRP could have a role in the GA treatment.
UNASSIGNED: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.