Veritti Daniele, Sarao Valentina, Diplotti Laura, Samassa Francesco, Lanzetta Paolo
a Department of Medicine - Ophthalmology , University of Udine , Udine , Italy.
b Istituto Europeo di Microchirurgia Oculare (IEMO) , Udine , Italy.
Expert Opin Pharmacother. 2017 Oct;18(14):1507-1516. doi: 10.1080/14656566.2017.1363182. Epub 2017 Aug 9.
Fluocinolone acetonide intravitreal implant is a non-erodible implant approved for the treatment of diabetic macular edema (DME) insufficiently responsive to available therapies. Areas covered: The injectable intravitreal implant releases fluocinolone acetonide at an average rate of 0.2 µg/day for at least 36 months. The two pooled pivotal FAME trials showed that, in patients with DME previously treated with laser photocoagulation, fluocinolone acetonide intravitreal implant was more beneficial than sham injection when looking at the proportion of patients with an improvement from baseline in visual acuity of more than 15 letters at 24 months and at 36 months. Cataract (82%) and intraocular pressure (IOP) elevation (37%) were the most common adverse events. Raised IOP was mostly treated with IOP-lowering medications, with <5% of eyes requiring incisional IOP-lowering surgery. FAME trial program results are confirmed by a series of real-world studies in eyes with chronic/recalcitrant DME. Expert opinion: data indicate that fluocinolone acetonide intravitreal implant is a useful second-line option for the treatment of DME.
曲安奈德玻璃体内植入剂是一种不可侵蚀的植入物，被批准用于治疗对现有疗法反应不足的糖尿病性黄斑水肿（DME）。涵盖领域：这种可注射的玻璃体内植入剂以平均每天0.2微克的速率释放曲安奈德，至少持续36个月。两项汇总的关键FAME试验表明，在先前接受过激光光凝治疗的DME患者中，从24个月和36个月时视力较基线提高超过15个字母的患者比例来看，曲安奈德玻璃体内植入剂比假注射更有益。白内障（82%）和眼压（IOP）升高（37%）是最常见的不良事件。眼压升高大多通过降低眼压的药物治疗，<5%的眼睛需要进行降低眼压的切开手术。FAME试验项目的结果在一系列针对慢性/顽固性DME眼睛的真实世界研究中得到了证实。专家意见：数据表明，曲安奈德玻璃体内植入剂是治疗DME的一种有用的二线选择。
