Intraocular injection

  • 文章类型: Journal Article
    背景:抗血管内皮生长因子(VEGF)通常使用prorenata或“治疗和延长”(T&E)方案治疗新生血管性年龄相关性黄斑变性(nAMD)。随机临床试验报道,T&E优于Prorenata(PRN),但是临床试验的结果可能并不总是在临床实践中复制。比较nAMD的T&E和PRN方案的实际数据有限。这项工作的目的是报告PRN与T&E方案在常规临床实践中治疗nAMD的24个月结局。
    方法:我们对前瞻性设计的观察结果登记数据进行了回顾性分析,对抗视网膜失明!项目(FRB)。通过使用FRB追踪开始使用T&E或PRN方案进行至少三次注射的nAMD治疗的未治疗眼睛。主要结果是视力(VA)的平均变化,通过在2年时与基线相比的最小分辨率角度图表的对数上读取的字母数量来测量。次要结果是2年时的注射次数。
    结果:从2015年1月1日至2019年1月31日,纳入了2948例nAMD患者的3313只眼:1065例患者的1243只眼被分类为PRN,1935例患者的2070只眼开始T&E方案。24个月时,接受T&E方案的患者在VA中的平均改善(95%置信区间)明显高于接受PRN的患者(+4.2[3.1,5.2]vs.+1.3[0.1,2.6]字母;p<0.001),更多的进样(14.9标准偏差(SD)4.3)与9.8(SD4.3);p<0.001)。
    结论:用T&E方案治疗的眼睛比治疗PRN的眼睛有更好的VA结果。这种大规模的现实世界数据评估支持了来自随机临床试验的先前数据,即T&E方案比PRN提供更好的结果。
    本研究重点是比较两种治疗新生血管性年龄相关性黄斑变性的方法,常见的眼部疾病.使用的治疗方法是雷珠单抗和阿柏西普。我们研究了反应性的“prorenata”方法,偶尔给予治疗,只有当病情恢复时,以及积极主动的“治疗和扩展”方法,其目的是通过最少的定期治疗来保持疾病不活跃。主要目的是确定哪种方法在24个月的时间内提供最佳的视力结果以及所需的治疗频率。我们发现,治疗和扩展方法比prorenata方法带来了更大的视力改善,尽管它确实需要更多的注射。这项研究强调了治疗和扩展方法对新生血管性年龄相关性黄斑变性的有效性,表明尽管需要更多的注射,它还是会得到更好的结果。
    BACKGROUND: Anti-vascular endothelial growth factor (VEGF) is generally given using pro re nata or \"treat-and-extend\" (T&E) regimens for neovascular age-related macular degeneration (nAMD). Randomized clinical trials have reported that T&E is superior to Pro re nata (PRN), but results from clinical trials may not always be replicated in clinical practice. Real-world data comparing T&E and PRN regimens for nAMD are limited. The objective of this work was to report 24-month outcomes of PRN versus T&E regimens for ranibizumab and aflibercept to treat nAMD in routine clinical practice.
    METHODS: We conducted a retrospective analysis of data from a prospectively designed observational outcomes registry, the Fight Retinal Blindness! Project (FRB). Treatment-naïve eyes starting nAMD treatment with at least three injections using a T&E or PRN regimen were tracked by using the FRB. The primary outcome was the mean change in visual acuity (VA) measured by the number of letters read on a logarithm of the minimum angle of resolution chart at 2 years versus baseline. The secondary outcome was the number of injections at 2 years.
    RESULTS: From January 1, 2015 to January 31, 2019, 3313 eyes from 2948 patients with nAMD were included: 1243 eyes from 1065 patients were classified as PRN and 2070 eyes from 1935 patients started a T&E regimen. At 24 months, patients on the T&E regimen experienced significantly greater mean (95% confidence interval) improvement in VA than those on PRN (+ 4.2 [3.1, 5.2] vs. + 1.3 [0.1, 2.6] letters; p < 0.001), with more injections (14.9 standard deviation(SD) 4.3) vs. 9.8(SD 4.3); p < 0.001).
    CONCLUSIONS: Eyes treated with a T&E regimen had better VA outcomes from VEGF inhibitors than eyes treated PRN. This large real-world data assessment supports previous data from randomized clinical trials that the T&E regimen delivers better outcomes than PRN.
    This study focused on comparing two methods of treating neovascular age-related macular degeneration, a common eye condition. The treatments used were ranibizumab and aflibercept. We looked at the reactive “pro re nata” method, where treatment is given sporadically and only when the condition reactivates, and the proactive “treat-and-extend” method, which aims to keep the disease inactive with the fewest treatments at regular intervals. The main aim was to determine which method provides the best vision outcomes over a 24-month period and the frequency of treatment required. We found that the treat-and-extend method resulted in a greater improvement in vision than the pro re nata method, although it did require more injections. This study highlights the effectiveness of the treat-and-extend method for neovascular age-related macular degeneration, suggesting it gets better outcomes despite requiring more injections.
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  • 文章类型: Journal Article
    持续释放,可生物降解,在开角型青光眼(OAG)和高眼压症(OHT)患者中,批准前房10-µg比马前列素植入物(Durysta)每只眼单次给药以降低眼内压(IOP).这项研究的目的是评估在现实世界的临床环境中OAG或OHT患者每只眼单次植入物给药的降低IOP的有效性和安全性。
    这是一个回顾,单中心研究包括105名在常规临床实践中使用比马前列素植入物的OAG或OHT连续成人患者。对初次植入给药后12个月或更长时间的患者的可用医疗记录进行审查。以及包括IOP在内的数据,降低IOP的药物和程序使用,收集和分析安全性结果.由于现实世界的设置,该分析使用了后续行动的范围。
    该研究包括197只眼睛(85.3%被诊断为OAG,94.9%假晶状体,和83.8%的角度等级4)。在比马前列素植入物给药后1年观察到IOP降低。基线时平均眼压为16.6mmHg,11-13个月时平均眼压为13.3mmHg,在第11~13个月时,使用的局部降眼压药物的平均数量从基线时的1.4减少到0.2.选择性激光小梁成形术(SLT)和比马前列素植入物治疗的眼睛中,IOP和降低IOP的药物使用类似地减少(包括66只眼在植入物给药前的最后一次SLT和28只眼在植入物给药后的最后一次SLT)。比马前列素植入物给药后,没有出现治疗性角膜水肿的病例,并且没有眼睛需要移除植入物。
    单次比马前列素植入物给药安全有效地降低了IOP长达1年,并减少了在有或没有先前或随后的SLT的OAG或OHT的眼中对局部降IOP药物的需要。
    UNASSIGNED: A sustained-release, biodegradable, intracameral 10-µg bimatoprost implant (Durysta) is approved for single administration per eye to lower intraocular pressure (IOP) in open-angle glaucoma (OAG) and ocular hypertension (OHT). The purpose of this study was to evaluate the IOP-lowering effectiveness and safety of a single implant administration per eye in patients with OAG or OHT in a real-world clinical setting.
    UNASSIGNED: This was a retrospective, single-site study involving 105 consecutive adult patients with OAG or OHT treated with the bimatoprost implant in 1 or both eyes in routine clinical practice. Available medical records of the patients for 12 months or longer after the initial implant administration were reviewed, and data including IOP, IOP-lowering medication and procedure use, and safety outcomes were collected and analyzed. The analysis used ranges of follow-up because of the real-world setting.
    UNASSIGNED: The study included 197 eyes (85.3% diagnosed with OAG, 94.9% pseudophakic, and 83.8% with angle grade 4). IOP reduction was observed through 1 year after the bimatoprost implant administration. Mean IOP was 16.6 mmHg at baseline and 13.3 mmHg at 11-13 months, with the mean number of topical IOP-lowering medications used reduced from 1.4 at baseline to 0.2 at 11-13 months. IOP and IOP-lowering medication use were similarly reduced in eyes treated with both selective laser trabeculoplasty (SLT) and bimatoprost implant (including 66 eyes with their last SLT before implant administration and 28 eyes with their last SLT after implant administration). There were no cases of treatment-emergent corneal edema after bimatoprost implant administration, and no eye required implant removal.
    UNASSIGNED: A single bimatoprost implant administration safely and effectively reduced IOP for up to 1 year and decreased the need for topical IOP-lowering medications in eyes with OAG or OHT with or without previous or subsequent SLT.
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  • 文章类型: Clinical Trial Protocol
    背景:无论是眼周注射还是眼内注射,皮质类固醇仍然是治疗炎症性黄斑水肿的重要工具。几年前,然而,只有曲安奈德可用于眼科医生.虽然这种化合物最初被开发用于风湿病或皮肤病学用途,它越来越多地应用于眼科,尽管仍然是标签外的。2011年,从可生物降解的地塞米松递送系统,玻璃体腔注射植入物获得批准用于炎性黄斑水肿。而曲安西龙治疗黄斑水肿的疗效和安全性,包括炎性水肿,已经被研究过了,目前没有关于结膜下注射曲安奈德的出版物,很简单,有效且耐受性良好。迄今为止,地塞米松700μg植入物已被批准用于治疗非感染性中间和后葡萄膜炎,但是还没有研究评估不同眼周和眼内策略的疗效和安全性,包括治疗炎性黄斑水肿。
    方法:因此,该方案旨在比较周围和眼内注射皮质类固醇治疗炎症性黄斑水肿的疗效和安全性。在这项正在进行的研究中,将包括142名患者,和水肿眼将被随机分配到结膜下注射曲安奈德或含有700μg地塞米松的玻璃体内植入物治疗。计划随访6个月,每月随访一次。每次访问将包括视敏度测量,裂隙灯检查,眼底镜检查,眼内压测量,激光耀斑测量(如果可用)和谱域光学相干层析成像。
    结论:如果证明在医生办公室进行的Kenacortretard®(即曲安西龙)注射成本仅为2.84欧元(没有额外的间接费用)至少与地塞米松700μg植入物(Ozurdex®,在专用房间进行的注射成本约960欧元)一样有效,则该试验的结果将对公共卫生产生真正的影响。没有增加的副作用。
    背景:ClinicalTrials.gov,NCT02556424。2015年9月22日注册。
    BACKGROUND: Whether they are injected peri- or intraocularly, corticosteroids are still essential tools in the therapeutic arsenal for treating inflammatory macular oedema. A few years ago, however, only triamcinolone acetonide was available to ophthalmologists. While this compound was initially developed for rheumatological or dermatological use, it has been increasingly deployed in ophthalmology, despite still being off-label. In 2011, the system for delivery of dexamethasone from a biodegradable, injectable implant into the vitreous cavity obtained approval for use in inflammatory macular oedema. While the efficacy and safety of triamcinolone in macular oedema, including inflammatory oedema, have already been studied, there are currently no publications on subconjunctival triamcinolone injections, which are simple, effective and well tolerated. To date, the dexamethasone 700 μg implant has been authorized for the treatment of noninfectious intermediate and posterior uveitis, but there have been no studies to evaluate the efficacy and safety of the different peri- and intraocular strategies, including the treatment of inflammatory macular oedema.
    METHODS: This protocol is therefore designed to compare the efficacy and safety of peri- and intraocular corticosteroid injections in the treatment of inflammatory macular oedema. In this ongoing study, 142 patients will be included, and the oedematous eye will be randomised to treatment with either subconjunctival triamcinolone injection or an intravitreal implant containing 700 μg dexamethasone. Follow-up is planned for 6 months with monthly visits. Each visit will include visual acuity measurement, a slit lamp examination, fundoscopy, intraocular pressure measurement, laser flare measurement (if available) and spectral domain optical coherence tomography.
    CONCLUSIONS: The results of this trial will have a real impact on public health if it is shown that a Kenacort retard® (i.e. triamcinolone) injection costing just €2.84 and performed in the physician\'s office (with no additional overhead costs) is at least as effective as the dexamethasone 700 μg implant (Ozurdex®; costing approximately €960 with the injection performed in a dedicated room), with no increased side effects.
    BACKGROUND: ClinicalTrials.gov, NCT02556424. Registered on 22 September 2015.
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