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.