Lanzetta Paolo, Korobelnik Jean-François, Heier Jeffrey S, Leal Sergio, Holz Frank G, Clark William Lloyd, Eichenbaum David, Iida Tomohiro, Sun Xiaodong, Berliner Alyson J, Schulze Andrea, Schmelter Thomas, Schmidt-Ott Ursula, Zhang Xin, Vitti Robert, Chu Karen W, Reed Kimberly, Rao Rohini, Bhore Rafia, Cheng Yenchieh, Wong Tien Y
Department of Medicine-Ophthalmology, University of Udine, and Istituto Europeo di Microchirurgia Oculare-IEMO, Udine-Milan, Italy.
CHU Bordeaux, Service d'Ophtalmologie, Bordeaux, France.
Ther Adv Ophthalmol. 2025 Aug 18;17:25158414251356388. doi: 10.1177/25158414251356388. eCollection 2025 Jan-Dec.
What is this summary about? • This is a summary of a publication about the PULSAR study, which was published in scientific journal. • Wet age-related (or AMD) is a long-term eye disease in which abnormal blood vessels grow in the back of the eye. As these vessels leak fluid or blood, the word "wet" is part of the disease name. This affects the central part of a person's vision, which can make it hard for people to read, drive, or perform other daily activities. It is one of the main causes of visual loss in older people, and if it is left untreated, it can lead to rapid loss of vision. • People with wet AMD can be treated with anti-vascular endothelial growth factor (or anti-) medicine, given as an injection into the back of the eye. This type of medicine can improve vision by directly reducing the leakage into the and by stopping the growth of new, abnormal blood vessels. This leads to reduced swelling of the , which is measured by central retinal thickness. These therapies need frequent eye injections. One of the biggest difficulties for many people and their caregivers is that they need to keep up with visits for their injections that are often required to maintain good vision. • is an anti- medicine that health authorities across different countries have approved for the treatment of wet AMD, as well as other eye diseases, which we will not discuss in this material. People with wet AMD can receive injections of 2 mg, given initially once per month for three months. After that, people usually receive treatment every 8 weeks, or sometimes less frequently, depending on their doctors' assessments of the disease state. • The PULSAR study was carried out to see if a higher, 8 mg, dose of would provide the same treatment results as 2 mg, but with the need for fewer injections. If fewer injections are necessary, this can potentially help patients and their caregivers keep up with treatment. • The PULSAR study involved a direct comparison of the two doses of this anti-VEGF medicine in patients with wet AMD who were placed into one of three treatment groups with different dosing intervals at random. What were the results? • Through the first year (or 48 weeks), participants who received injections of 8 mg every 12 or 16 weeks after an injection once per month for three months, had improvements in vision that were similar to those of participants treated with 2 mg every 8 weeks. • After the injection once per month for three months, at Week 16, there were fewer participants treated with the 8 mg dose who had abnormal fluid leakage in the compared to the 2 mg dose. • At Week 48, participants who received 8 mg had similar decreases in the thickness of the retina in the central region as those treated with 2 mg. • Most participants who received 8 mg and completed 48 weeks of the study maintained their 12- or 16-week injection schedules, without needing to shorten the interval between injections. • Adverse events in participants treated with 8 mg were also similar to those in participants treated with 2 mg. What do the results mean? • Findings show that 8 mg can improve vision to the same extent as 2 mg in people with wet AMD, but with fewer injections than 2 mg so that people can potentially keep up with their treatments more easily.
本总结是关于什么的?
• 这是一篇发表在科学期刊上关于PULSAR研究的出版物总结。
• 湿性年龄相关性黄斑变性(或湿性AMD)是一种长期的眼部疾病,眼部后方会生长异常血管。由于这些血管渗漏液体或血液,所以“湿性”是该疾病名称的一部分。这会影响人的中央视力,使人难以阅读、驾驶或进行其他日常活动。它是老年人视力丧失的主要原因之一,如果不治疗,可能会导致视力迅速丧失。
• 湿性AMD患者可以通过向眼后注射抗血管内皮生长因子(或抗VEGF)药物进行治疗。这类药物可以通过直接减少渗漏到视网膜下腔的液体,并阻止新的异常血管生长来改善视力。这会使视网膜下腔肿胀减轻,通过中心视网膜厚度来衡量。这些治疗需要频繁的眼部注射。对许多患者及其护理人员来说,最大的困难之一是他们需要定期进行注射以维持良好视力。
• 阿柏西普是一种抗VEGF药物,不同国家的卫生当局已批准其用于治疗湿性AMD以及其他眼部疾病,本材料中对此将不作讨论。湿性AMD患者可以接受2毫克阿柏西普注射,最初每月注射一次,共注射三个月。之后,患者通常每8周接受一次治疗,有时根据医生对病情的评估,注射频率会更低。
• PULSAR研究旨在探究更高剂量(8毫克)的阿柏西普是否能与2毫克剂量产生相同的治疗效果,但所需注射次数更少。如果所需注射次数更少,这可能会帮助患者及其护理人员坚持治疗。
• PULSAR研究对湿性AMD患者直接比较了两种剂量的这种抗VEGF药物,这些患者被随机分为三个治疗组,每组有不同的给药间隔。
研究结果是什么?
• 在第一年(或48周),在最初每月注射一次,共注射三个月后,每12周或16周接受一次8毫克阿柏西普注射的参与者,其视力改善情况与每8周接受一次2毫克阿柏西普治疗的参与者相似。
• 在最初每月注射一次,共注射三个月后,在第16周时,接受8毫克剂量治疗的参与者中,视网膜下腔出现异常液体渗漏的人数比接受2毫克剂量治疗的参与者更少。
• 在第48周时,接受8毫克阿柏西普治疗的参与者中央视网膜区域厚度的减少情况与接受2毫克治疗的参与者相似。
• 大多数接受8毫克阿柏西普治疗并完成48周研究的参与者维持了他们每12周或16周的注射计划,无需缩短注射间隔。
• 接受8毫克阿柏西普治疗的参与者的不良事件也与接受2毫克治疗的参与者相似。
这些结果意味着什么?
• 研究结果表明,8毫克阿柏西普在湿性AMD患者中改善视力的程度与2毫克阿柏西普相同,但注射次数比2毫克阿柏西普少,因此患者可能更容易坚持治疗。