Eichenbaum David A, Duerr Emily, Patel Hershel R, Pollack Scott M
Ophthalmic Surg Lasers Imaging Retina. 2018 Nov 1;49(11):e191-e197. doi: 10.3928/23258160-20181101-17.
Compare fixed monthly dosing of ranibizumab to treat-and-extend (T&E) ranibizumab during a period of 24 months for diabetic macular edema (DME) treatment.
Single-center, randomized, prospective pilot study that included 20 eyes of 20 subjects. Patients' best-corrected visual acuity (BCVA) was less than or equal to 20/40 and central foveal thickness on spectral-domain optical coherence tomography was greater than 325 µm. Intravitreal ranibizumab was dosed monthly or by protocol-specified treat-and-extend. Primary outcome was mean change in mean BCVA. Institutional review board approval was obtained.
At month 24 (M24), there was a mean 8.3-letter gain in the monthly treatment group and an 8.5-letter gain in the T&E group (P = .082; 90% confidence interval). The average change from baseline BCVA was not statistically significantly different at any timepoint. At M24, the median number of injections in the monthly and T&E groups were 22.5 and 18.5, respectively (P = .287).
Visual acuity with monthly dosing appears equivalent to T&E dosing during the course of 24 months. There was a trend toward a lower injection burden in the T&E arm. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:e191-e197.].
比较雷珠单抗固定每月给药方案与治疗并延长（T&E）给药方案在24个月期间治疗糖尿病性黄斑水肿（DME）的效果。
一项单中心、随机、前瞻性试点研究，纳入了20名受试者的20只眼。患者的最佳矫正视力（BCVA）小于或等于20/40，且光谱域光学相干断层扫描显示中心凹厚度大于325µm。玻璃体内注射雷珠单抗采用每月给药或根据方案指定的治疗并延长给药方式。主要结局指标为平均BCVA的平均变化。获得了机构审查委员会的批准。
在第24个月（M24）时，每月治疗组的平均视力提高了8.3个字母，T&E组提高了8.5个字母（P = 0.082；90%置信区间）。在任何时间点，与基线BCVA相比的平均变化均无统计学显著差异。在M24时，每月治疗组和T&E组的注射次数中位数分别为22.5次和18.5次（P = 0.287）。
在24个月的疗程中，每月给药的视力改善效果似乎与T&E给药相当。T&E组的注射负担有降低的趋势。[《眼科手术、激光与视网膜成像》。2018；49：e191 - e197。]
