背景:黄斑水肿(ME)是由视网膜血管的高通透性引起的,导致血浆成分慢性外渗到视网膜中,因此可能导致严重的视力丧失。目前的护理标准包括使用玻璃体内注射(IVI),这导致了巨大的医疗和经济负担。在糖尿病性视网膜病变(DR)或视网膜静脉阻塞(RVO)期间,最近已经表明,局灶性血管异常(毛细血管大动脉瘤,也称为TelCaps)的毛细血管扩张可能在发作中起核心作用,早期复发,和/或我的持久性。由于TelCaps的靶向光凝可以改善视力,identification,和TelCaps的光凝,它可能代表了一种改善ME管理的方法。
目的:(糖尿病)黄斑水肿的靶向激光(TalaDME)研究旨在评估ICG引导的靶向激光(IGTL)是否,与IVI的护理标准相关,与仅IVI相比,允许减少治疗第一年的注射次数,同时保持视力不差。
方法:TalaDME是法语,多中心,双臂,随机化,假激光控制,双掩蔽试验评估TelCaps光凝联合IVI对与TelCaps相关的ME患者的影响。与中心相关的视力丧失涉及RVO或DR继发ME并出现TelCaps的患者符合资格。270名患者的二百七十只眼以1:1的比例随机分配给标准护理,即,抗VEGF单独治疗(对照组)或联合IGTL治疗(实验组)。分层是根据ME的原因进行的(即,RVO与糖尿病)。每月向两组施用抗VEGFIVI,持续3个月(负荷剂量),然后使用prorenata方案,每月随访12个月。主要终点是IVI的数量和从基线到12个月的视力变化。次要终点将是黄斑中心厚度的变化,对生活质量的影响,治疗费用,和每组的增量成本-效用比。
■与使用IVI和激光有关的罕见但严重的AE,之前描述过,是预期的。在假小组中,如果认为有必要,在第3个月时,未掩盖的研究者可进行抢救激光光凝.
结论:对与TelCaps相关的ME的最佳管理进行了辩论,也没有随机研究来回答这个问题。鉴于TelCaps可能会影响30%至60%的因DR或RVO引起的慢性ME患者,大量患者可以从TelCaps的特定管理中受益.TalaDME旨在建立额外靶向激光的临床和医学经济效益。TalaDME的结果可能为管理ME和影响医疗保健成本提出新的建议。
背景:EudraCT:2018-A00800-55/NCT03751501。注册日期:11月23,2018.
BACKGROUND: Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of care consists in using intravitreal injections (IVI), which results in a significant medical and economic burden. During diabetic retinopathy (DR) or retinal vein occlusion (RVO), it has recently been shown that focal vascular anomalies (capillary macro-aneurysms, also termed TelCaps) for telangiectatic capillaries may play a central role in the onset, early recurrence, and/or persistence of ME. Since targeted
photocoagulation of TelCaps may improve vision, identification, and
photocoagulation of TelCaps, it may represent a way to improve management of ME.
OBJECTIVE: The Targeted Laser in (Diabetic) Macular Edema (TalaDME) study aims to evaluate whether ICG-guided targeted laser (IGTL), in association with standard of care by IVI, allows reducing the number of injections during the first year of treatment compared with IVI only, while remaining non-inferior for visual acuity.
METHODS: TalaDME is a French, multicentric, two-arms, randomized, sham laser-controlled, double-masked trial evaluating the effect of
photocoagulation of TelCaps combined to IVI in patients with ME associated with TelCaps. Patients with vision loss related to center involved ME secondary to RVO or DR and presenting TelCaps are eligible. Two hundred and seventy eyes of 270 patients are randomized in a 1:1 ratio to standard care, i.e., IVI of anti-VEGF solely (control group) or combined with IGTL therapy (experimental group). Stratification is done on the cause of ME (i.e., RVO versus diabetes). Anti-VEGF IVI are administered to both groups monthly for 3 months (loading dose) and then with a pro re nata regimen with a monthly follow-up for 12 months. The primary endpoint will be the number of IVI and the change in visual acuity from baseline to 12 months. Secondary endpoints will be the changes in central macular thickness, impact on quality of life, cost of treatment, and incremental cost-utility ratio in each groups.
UNASSIGNED: Rare but severe AE linked to the use of IVI and laser, and previously described, are expected. In the sham group, rescue laser
photocoagulation may be administered by the unmasked investigator if deemed necessary at month 3.
CONCLUSIONS: The best management of ME associated with TelCaps is debated, and there have been no randomized study designed to answer this question. Given the fact that TelCaps may affect 30 to 60% of patients with chronic ME due to DR or RVO, a large number of patients could benefit from a specific management of TelCaps. TalaDME aims to establish the clinical and medico-economic benefits of additional targeted laser. The results of TalaDME may raise new recommendations for managing ME and impact healthcare costs.
BACKGROUND: EudraCT: 2018-A00800-55/ NCT03751501. Registration date: Nov. 23, 2018.