de Andrade Gabriel Costa, de Oliveira Dias João Rafael, Maia André, Farah Michel Eid, Meyer Carsten H, Rodrigues Eduardo Buchele
Ophthalmic Surg Lasers Imaging Retina. 2018 Apr 1;49(4):245-250. doi: 10.3928/23258160-20180329-06.
To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME).
Seven consecutive patients with DME were enrolled and submitted to 12 consecutive IVI-ZA with a 4-week interval. The safety parameters included changes in full-field electroretinogram (ERG) and systemic or ocular complications, and the efficacy parameters were the mean change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT).
No significant differences were found in any ERG component after IVI-ZA, and no systemic or ocular complication was observed. The improvement of BCVA was most significant after the first IVI-ZA and remained until week 48 (P < .05). The CRT significantly decreased during the course of 48 weeks.
The 48-week results are consistent with our previous 24-week findings, supporting IVI-ZA as a safe, efficient, and well-tolerated therapy for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:245-250.].
研究玻璃体内注射阿柏西普(IVI-ZA)(Zaltrap;赛诺菲-安万特公司和再生元制药公司,纽约塔里敦)48周期间对糖尿病性黄斑水肿(DME)患者的安全性和有效性。
连续纳入7例DME患者,每隔4周连续进行12次IVI-ZA注射。安全性参数包括全视野视网膜电图(ERG)的变化以及全身或眼部并发症,有效性参数为最佳矫正视力(BCVA)和中心视网膜厚度(CRT)相对于基线的平均变化。
IVI-ZA注射后,任何ERG成分均未发现显著差异,也未观察到全身或眼部并发症。首次IVI-ZA注射后BCVA改善最为显著,且持续至48周(P <.05)。48周内CRT显著降低。
48周的结果与我们之前24周的研究结果一致,支持IVI-ZA作为一种对DME患者安全、有效且耐受性良好的治疗方法。[《眼科手术、激光与视网膜成像》。2018年;49:245 - 250。]