ILUVIEN

Iluvien
  • 文章类型: Journal Article
    背景:影响眼睛后段的非感染性葡萄膜炎(NIU-PS)是一种炎症性疾病,如果不充分治疗,可能会严重损害视力。氟轻松-丙酮持续释放-0.2µg/天玻璃体内(FAc)植入物可用于预防复发性NIU-PS的复发。这里的目的是为临床医生提供一些基于共识的建议,用于使用0.2µg/天FAc植入物的NIU-PS患者的临床管理。
    方法:一个欧洲临床专家组同意就NIU-PS患者使用FAc植入物的不同问题制定一份共识报告。
    结果:临床专家小组针对NIU-PS的临床表现(单侧/双侧);NIU-PS的全身受累和晶状体状态提供了具体建议。开发了治疗算法;一个是指在临床实践中对NIU-PS患者的管理,另一个是建立使用FAc植入物的最佳临床方案,作为单一疗法和辅助疗法。此外,临床专家小组提供了有关在临床中使用FAc植入物的建议.临床专家小组还考虑了FAc植入物的安全性及其在日常实践中的可能影响。
    结论:随着使用FAc植入物获得更多临床经验,有必要更新指导临床患者管理的临床建议.当前的共识文件解决了与不同类型的NIU-PS病因不同的患者使用FAc植入物相关的问题,并进行了标准化方法,以帮助专家获得更好的临床结果。
    BACKGROUND: Non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) is an inflammatory disease, which can significantly impair visual acuity if not adequately treated. Fluocinolone-acetonide sustained-release-0.2 µg/day intravitreal (FAc) implants are indicated for prevention of relapse in recurrent NIU-PS. The aim here was to provide treating clinicians with some consensus-based-recommendations for the clinical management of patients with NIU-PS with 0.2 µg/day FAc implants.
    METHODS: A European-clinical-expert-group agreed to develop a consensus report on different issues related to the use of FAc implants in patients with NIU-PS.
    RESULTS: The Clinical-expert-panel provided specific recommendations focusing on clinical presentation (unilateral/bilateral) of the NIU-PS; systemic involvement of NIU-PS and the lens status. Treatment algorithms were developed; one that refers to the management of patients with NIU-PS in clinical practice and another that establishes the best clinical scenarios for the use of FAc implants, both as monotherapy and as adjuvant therapy. Additionally, the Clinical-expert-panel has provided recommendations about the use of the FAc implants in a clinical-setting. The Clinical-expert-panel also considered the safety profile of FAc implants and their possible implications in the daily practice.
    CONCLUSIONS: As more clinical experience has been gained using FAc implants, it was necessary to update the clinical recommendations that guide patient management in the clinic. The current consensus document addresses relevant issues related to the use of FAc implants on different types of patients with various etiologies of NIU-PS, and was conducted to standardize approaches to help specialists obtain better clinical outcomes.
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  • 文章类型: Journal Article
    黄斑水肿(ME)仍然是葡萄膜炎视力恶化的主要原因。视力(VA)通常可以使用皮质类固醇储库系统来维持。这项研究使用真实世界数据评估了氟轻松(FAc)玻璃体内植入物(ILUNEN®)治疗非感染性葡萄膜炎的疗效。这项回顾性分析包括135只眼睛,细分为响应者和非响应者。中央视网膜厚度(CRT),VA,和眼压(IOP)随时间的推移进行随访。在整个随访期间,观察到所有眼睛的CRT显着降低和VA增加(p<0.01)。IOP增加(p=0.028)需要到第6个月治疗43%的眼睛。无反应者年龄较大(p=0.004),并接受了更多的地塞米松(DEX)植入物治疗(p=0.04);89.3%的外界膜(ELM)和内/外节(IS/OS)区存在缺陷(p<0.001)。免疫调节治疗对治疗反应无影响。与非PPV患者相比,平坦部玻璃体切除术(PPV)患者的平均CRT降低为47.55µm,并且到第24个月时效果降低(p=0.046)。我们得出的结论是,FAc植入物可实现对CRT的长期控制并改善VA。IOP的增加是可控的。具有先前PPV的眼睛显示较温和的结果。数据显示老年人之间存在相关性,损坏的ELM和IS/OS区域,频繁的DEX插入,和较差的结果衡量标准。
    Macular edema (ME) remains a primary cause of visual deterioration in uveitis. Visual acuity (VA) can often be maintained using corticosteroid depot systems. This study evaluated the efficacy of a fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) in treating non-infectious uveitis using real-world data. This retrospective analysis included 135 eyes subdivided into responders and non-responders. Central retinal thickness (CRT), VA, and intraocular pressure (IOP) were followed over time. A significant decrease in CRT and an increase in VA were observed in all eyes throughout the follow-up period (p < 0.01). An IOP increase (p = 0.028) necessitated treatment in 43% of eyes by Month 6. Non-responders were older (p = 0.004) and had been treated with more dexamethasone (DEX) implants (p = 0.04); 89.3% had a defect in the external limiting membrane (ELM) and inner/outer segment (IS/OS) zone (p < 0.001). Immunomodulatory therapy had no impact on treatment response. Pars plana vitrectomy (PPV) patients had a mean CRT reduction of 47.55 µm and a reduced effect by Month 24 (p = 0.046) versus non-PPV patients. We conclude that the FAc implant achieves long-term control of CRT and improves VA. Increases in IOP were manageable. Eyes with a previous PPV showed milder results. Data showed a correlation between older age, a damaged ELM and IS/OS zone, frequent DEX inserts, and poorer outcome measures.
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  • 文章类型: Journal Article
    目的:糖尿病性黄斑水肿(DME)在临床实践中仍然存在问题,许多患者对护理标准(SOC)的反应欠佳。有证据支持玻璃体内注射氟轻松(FAc)植入物(ILUNEN®)对反应欠佳的患者的长期疗效,尽管来自现实世界葡萄牙实践的数据仍然很少。我们旨在在FAc植入前监测选定的葡萄牙实践中的当前SOC,然后评估FAc植入的长期有效性和安全性。
    方法:该研究包括来自五家葡萄牙公立医院的患者数据。
    方法:这是非干预性的,对从Retina收集的数据进行多中心审计。尽管接受了治疗,但仍有持续性或复发性DME患者的pt登记。
    方法:结果测量包括最佳矫正视力(BCVA)的变化,黄斑中心厚度(CMT),和眼内压(IOP)。在36个月内定期比较结果。
    结果:本研究包括152名患者的222只眼。在FAc之前观察到BCVA的显着降低(P<0.001)和CMT的显着增加(P=0.013)。FAc植入物给药后6个月,BCVA显着增加(P<0.001),在随访期间保持不变。未观察到IOP的相关变化。由于用FAc治疗,治疗负担降低(抗VEGF的P<0.001,皮质类固醇,或两种治疗)在全部人群中。
    结论:在葡萄牙语实践中,数据显示,前FAc植入,一些患者对SOC治疗无反应和/或治疗不足.FAc植入后,很快,持续,长期的视觉和解剖学改善,治疗负担明显减轻。
    OBJECTIVE: Persistent diabetic macular edema (DME) remains a problem in clinical practice, with many patients having a suboptimal response to the standard of care (SOC). Evidence supports the long-term efficacy of intravitreal fluocinolone acetonide (FAc) implant (ILUVIEN®) in patients that have responded sub-optimally, although there is still scarce data from real-world Portuguese practices. We aimed to monitor the current SOC in selected Portuguese practices prior to FAc implantation and then assess the long-term effectiveness and safety of the FAc implant.
    METHODS: The study included patient data from five Portuguese public hospitals.
    METHODS: This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment.
    METHODS: Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months.
    RESULTS: This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population.
    CONCLUSIONS: In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.
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  • 文章类型: Journal Article
    氟轻松(FAc)玻璃体内植入物(Iluvien®)是一种皮质类固醇植入物,适用于先前接受常规治疗但没有良好反应的患者的糖尿病性黄斑水肿(DMO)的治疗,非感染性后葡萄膜炎,并作为视网膜静脉阻塞继发的黄斑水肿的标签外治疗。FAc是不可生物降解的0.19mg玻璃体内植入物,其被设计为以每天约0.2mcg的速率在3年内释放FAc。这篇综述的目的是描述Iluvien的特殊药理特性,并显示有关其治疗上述视网膜疾病的有效性和安全性的最重要的临床试验和现实世界研究的结果。
    Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.
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  • 文章类型: Journal Article
    目的:显示一种替代的手术技术,用于使用23号(G)套管针将玻璃体内的氟轻松(FAc)植入物(Iluvien®)引入玻璃体腔,如果其在结膜下空间的植入过程中保留。
    方法:我们描述了为解决并发症而进行的外科手术:使用扁平视网膜镊子从结膜下间隙中提取FAc植入物。将23-G套管针插入到角膜缘3.5mm处。使用相同的扁平视网膜镊子取出FAc植入物并使用23-G套管针将其引入玻璃体腔。
    结果:患者的最佳矫正视力(BCVA)(Snellen)从20/200提高到20/63,黄斑中心厚度(CMT)从610微米(µm)降低到215µm。他在3个月的随访后保持稳定,BCVA为20/63,CMT为191µm。他的眼内压(IOP)保持稳定,并通过间接检眼镜检查植入物的完整性。
    结论:如果在结膜下空间的植入过程中保留了使用23号套管针的玻璃体内FAc植入物,则是一种有效的替代方法。植入物的功能在我们的患者中保持完整。
    OBJECTIVE: To show an alternative surgical technique for the introduction of the intravitreal fluocinolone acetonide (FAc) implant (Iluvien®) into the vitreous cavity using a 23-gauge (G) trocar if it is retained during its implantation in the subconjunctival space.
    METHODS: We describe the surgical procedure performed to solve the complication: The FAc implant was extracted from the subconjunctival space using flat retinal forceps. A 23-G trocar was inserted 3,5 mm to the limbus. The same flat retinal forceps were used to take the FAc implant and introduce it into the vitreous cavity using a 23-G trocar.
    RESULTS: The patient\'s best corrected visual acuity (BCVA) (Snellen) improved from 20/200 to 20/63 and the central macular thickness (CMT) was reduced from 610 microns (µm) to 215 µm after one week of the FAc implantation. He remained stable after 3 months of follow-up, with a BCVA of 20/63 and a CMT of 191 µm. His intraocular pressure (IOP) remained stable and the integrity of the implant was checked by indirect ophthalmoscopy.
    CONCLUSIONS: The introduction of the intravitreal FAc implant using a 23-gauge trocar constitutes a valid alternative if it is retained during its implantation in the subconjunctival space.The functionality of the implant remained intact in our patient.
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  • 文章类型: Journal Article
    背景:0.19mg醋酸氟轻松(FAc)玻璃体内植入物可连续注射皮质类固醇,用于治疗难治性糖尿病性黄斑水肿(DMO)。这项研究的目的是评估FAc玻璃体内植入物对眼内压(IOP)的影响。
    方法:我们回顾性收集了患者特征的匿名数据,DMO治疗,以及2013年9月至2020年3月期间在几个欧洲中心进行的FAc玻璃体内植入前后的IOP和降IOP治疗。
    结果:共纳入179例患者的221只眼。平均随访时间为13.4(±12.5,范围2.4-33.5)个月。总的来说,194只眼(88.2%)在FAc玻璃体内植入前接受了玻璃体内注射地塞米松。25眼(11.3%)有青光眼病史,52眼(23.5%)曾接受过降低IOP治疗。注射前平均IOP为14.7(3.4)mmHg,注射后12个月增加至16.9(3.7)mmHg(P<0.0001)。随访期间,55只眼睛(24.9%)需要添加或开始局部降眼压药物,只有一名患者(0.5%)进行了激光小梁成形术,一名患者(0.5%)进行了微创青光眼手术,并且没有患者需要进行降低IOP的手术。
    结论:FAc玻璃体内植入导致IOP显著升高。在添加或开始局部IOP降低药物的情况下,大多数时间都会监测这种升高。
    BACKGROUND: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant delivers a continuous intravitreal corticosteroid dose for the treatment of refractory diabetic macular oedema (DMO). The aim of this study was to assess the impact of an FAc intravitreal implant on intraocular pressure (IOP).
    METHODS: We retrospectively collected anonymised data on the patients\' characteristics, DMO treatment, and IOP and IOP-lowering treatments before and after the FAc intravitreal implant between September 2013 and March 2020 in several European centres.
    RESULTS: A total of 221 eyes from 179 patients were included. The mean follow-up duration was 13.4 (± 12.5, range 2.4-33.5) months. Overall, 194 eyes (88.2%) had received an intravitreal dexamethasone injection before the FAc intravitreal implant. For 25 eyes (11.3%) there was a history of glaucoma, and 52 eyes (23.5%) had previous IOP-lowering treatment. Mean IOP before injection was 14.7 (3.4) mmHg and increased to 16.9 (3.7) mmHg 12 months after injection (P < 0.0001). During follow-up, 55 eyes (24.9%) required the addition or initiation of topical IOP-lowering medication, only one patient (0.5%) had laser trabeculoplasty and one patient (0.5%) a minimally invasive glaucoma surgery, and no patient required incisional IOP-lowering surgery.
    CONCLUSIONS: The FAc intravitreal implant led to substantial IOP elevation. This elevation was monitored most of the time with addition or initiation of topical IOP-lowering medication.
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  • 文章类型: Journal Article
    在过去的十年中,持续释放的皮质类固醇植入物的开发彻底改变了影响眼后段的非感染性葡萄膜炎的治疗。它们的使用现在得到了医疗保健系统的支持,这些系统已经根据高质量的随机对照试验获得了许可和委托,这些试验是其开发的一部分,并已告知临床医生其益处和风险。特别是,他们为不希望全身免疫抑制的患者提供了一种替代治疗模式,或者这种免疫抑制不太可取的人,例如患有单侧疾病或患有糖尿病等并发疾病的患者,受到全身性皮质类固醇或其他免疫抑制剂负面影响的肾脏疾病或骨质疏松症。在这篇文章中,我们回顾了使用主要许可的皮质类固醇植入物的证据,并评估了每种植入物的优缺点.
    The treatment of non-infectious uveitis affecting the posterior segment of the eye has been revolutionized by the development of sustained-release corticosteroid implants over the past decade. Their use is now supported by healthcare systems that have licensed and commissioned them on the basis of the high-quality randomised controlled trials that formed part of their development and which have informed clinicians as to their benefits and risks. In particular, they have provided an alternative mode of treatment for patients who do not wish to be systemically immunosuppressed, or in whom such immunosuppression is less desirable, such as those with unilateral disease or those with concurrent illnesses such as diabetes mellitus, renal disease or osteoporosis that are negatively impacted by systemic corticosteroids or other immunosuppressive agents. In this article, we review the evidence for the use of the major licensed corticosteroid implants and assess the advantages and disadvantages of each.
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  • 文章类型: Journal Article
    背景:本研究的目的是使用光学相干断层扫描血管造影术(OCTA)研究患有糖尿病性黄斑水肿(DME)并接受0.19mgILUVIEW®(氟轻松玻璃体内植入物)治疗的患者的黄斑灌注变化。
    方法:这是一项回顾性队列研究,包括年龄>18岁的2型非增生性糖尿病视网膜病变(DR)和DME患者。所有患者均接受ILUNEN®植入物治疗。至少需要两次6×6-mmOCTA扫描,以确保所有病例在随访4个月时都有基线OCTA和OCTA。进行了定性和定量比较。
    结果:分析中包括来自10名受试者的10只眼睛。研究队列的平均(±标准差)年龄为57.1±8.3岁。基线时的平均旁凹灌注密度(PD)为基线时的64.1±1.8%,在4个月的随访中增加到66.1±2.9%(p=0.013)。基线时的平均旁凹PD为64.4±2.1%,4个月后增加到65.2±2.6%(p=0.024)。在定性评估中,对60个区域(每个受试者10个区域)进行分级以评估基线和随访之间的视网膜灌注变化。这项评估显示,24个区域(40.0%)的特点是治疗后灌注的定性增加,而22(36.7%)和14(23.3%)区域的特点是稳定和减少视网膜灌注,分别。
    结论:OCTA分析检测到ILUNEN®治疗后黄斑灌注的改善。黄斑灌注的这种改善可能与皮质类固醇相关的对白细胞淤滞的有益作用有关。
    BACKGROUND: The aim of this study was to investigate changes in macular perfusion in patients affected by diabetic macular edema (DME) and treated with ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg using optical coherence tomography angiography (OCTA).
    METHODS: This was a retrospective cohort study that included patients aged > 18 years with type 2 non-proliferative diabetic retinopathy (DR) and DME at baseline. All patients were treated with the ILUVIEN® implant. A minimum of two 6 × 6-mm OCTA scans were required to ensure that all cases had a baseline OCTA and an OCTA performed at 4 months of follow-up. Qualitative and quantitative comparisons were performed.
    RESULTS: Ten eyes from ten subjects were included in the analysis. Mean (± standard deviation) age of the study cohort was 57.1 ± 8.3 years. Mean parafoveal perfusion density (PD) at baseline was 64.1 ± 1.8% at baseline, increasing to 66.1 ± 2.9% (p = 0.013) at the 4-month follow-up visit. Mean parafoveal PD at baseline was 64.4 ± 2.1%, increasing to 65.2 ± 2.6% (p = 0.024) after 4 months. In the qualitative assessment, 60 regions (10 areas for each subject) were graded to assess changes in retinal perfusion between the baseline and follow-up visits. This assessment revealed that 24 regions (40.0%) were characterized by a qualitative increase in perfusion after treatment, while 22 (36.7%) and 14 (23.3%) regions were featured by a stability and reduction in retinal perfusion, respectively.
    CONCLUSIONS: OCTA analysis detects improvements in macular perfusion after treatment with ILUVIEN®. This improvement in macular perfusion may be associated with corticosteroid-related beneficial effects on leukostasis.
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  • 文章类型: Journal Article
    黄斑囊样水肿(CME)是玻璃体切除术和白内障手术后视力下降的最常见原因。已经使用了各种策略来治疗它,如玻璃体内皮质类固醇。玻璃体内氟轻松酮植入物(Iluvien®)被批准用于治疗持续性糖尿病性黄斑水肿和预防影响后段的非感染性葡萄膜炎的复发。关于其用于手术后CME的标签外使用的报道很少。我们介绍了4例术后CME的临床病例(2年前在玻璃体切除术后进行玻璃体切除术后进行了3例,在白内障手术后进行了1例)。所有这些患者之前平均注射了四次玻璃体内地塞米松植入物(Ozurdex®),CME反复复发。用Iluvien治疗后,3例患者视力和黄斑解剖都有改善,黄斑水肿的消退。一名患者在随访期间需要使用Ozurdex进行额外治疗,进一步完善CME。其中两例需要局部降压治疗,也没有人需要做过滤手术.Iluvien可能是其他玻璃体内治疗难治性玻璃体切除术或白内障手术后持续性非糖尿病性黄斑水肿的有效治疗选择。能够提供更长的无复发期。
    Cystoid macular edema (CME) is the most common cause of decreased visual acuity after both vitrectomy and cataract surgery. Various strategies have been used for its treatment, such as intravitreal corticosteroids. The intravitreal fluocinolone acetonide implant (Iluvien®) is approved for the treatment of persisting diabetic macular edema and for the prevention of recurrence of non-infectious uveitis affecting the posterior segment. There are very few reports about its off-label use for post-surgical CME. We present four clinical cases of post-surgical CME (three following vitrectomy and one following cataract surgery in a vitrectomized eye 2 years ago). All of them had been previously treated with an average of four injections of intravitreal dexamethasone implant (Ozurdex®), with repeated recurrence of CME. After treatment with Iluvien, three cases showed improvement of both visual acuity and macular anatomy, with resolution of the macular edema. One patient required additional treatment with Ozurdex during follow-up, further improving CME. Two of the cases required topical pressure lowering treatment, and none required filtering surgery. Iluvien could be an effective therapeutic option for persistent non-diabetic macular edema after vitrectomy or cataract surgery refractory to other intravitreal therapies, with the benefit of being able to provide longer recurrence-free periods.
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  • 文章类型: Case Reports
    Idiopathic retinal vasculitis, aneurysms, and neuroretinitis (IRVAN) syndrome is a rare and progressive disorder that predominantly affects both the eyes of young female individuals and can threaten visual function. Peripheral ischemia and macular exudation are common findings in patients. The treatment options include panretinal photocoagulation (PRP), systemic immunosuppression, and intravitreal antiangiogenic and corticosteroid therapy. Fluocinolone acetonide intravitreal implant is approved for the treatment of nonanterior noninfectious uveitis and diabetic macular edema (ME), with an estimated therapeutic duration of 3 years. We describe a case of IRVAN syndrome in a child with ME who had been previously treated with PRP, antiangiogenic therapy, and several dexamethasone intravitreal implants and received a fluocinolone acetonide intravitreal implant in her right eye. The patient showed stabilization of the visual acuity and a marked reduction of the macular thickness 1 month after the treatment. At 12-month follow-up, the patient required perifoveal focal photocoagulation due to a rebound of the ME. After 2 years of follow-up, visual acuity remains stable and macular retinal thickening under control. Local long-standing steroid therapy has proved to be quite efficient in controlling the progression of the disease in our patient.
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