Lalwani Geeta A, Rosenfeld Philip J, Fung Anne E, Dubovy Sander R, Michels Stephen, Feuer William, Davis Janet L, Flynn Harry W, Esquiabro Maria
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida 33136, USA.
Am J Ophthalmol. 2009 Jul;148(1):43-58.e1. doi: 10.1016/j.ajo.2009.01.024. Epub 2009 Apr 18.
To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years.
A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT.
In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 microm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 microm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT.
Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 microm (P < .001). VA improved by 15 letters or more in 43% of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months.
The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.
在一项使用雷珠单抗的可变剂量方案治疗新生血管性年龄相关性黄斑变性（AMD）患者的前瞻性光学相干断层扫描（OCT）成像研究（PrONTO研究）中，对患者进行了2年的随访，以评估该方案的长期疗效。
一项为期2年的前瞻性、非对照、基于OCT的玻璃体内注射雷珠单抗可变剂量方案研究。
在这项开放标签、前瞻性、单中心、非对照临床研究中，纳入了新生血管累及中央凹且经OCT测量中央视网膜厚度（CRT）至少为300微米的AMD患者，接受连续3个月每月1次玻璃体内注射雷珠单抗（0.5毫克）[Lucentis；美国加利福尼亚州南旧金山基因泰克公司]。在第一年，如果满足任何标准，如OCT-CRT增加至少100微米或视力下降5个字母或更多，则在每月随访时进行雷珠单抗再治疗。在第二年，再治疗标准修改为如果使用OCT检测到液体量有任何定性增加则进行再治疗。
40名患者入组，37名完成了2年研究。在第24个月时，平均视力（VA）提高了11.1个字母（P <.001），OCT-CRT下降了212微米（P <.001）。43%的患者视力提高了15个字母或更多。在24个月内平均注射9.9次就实现了这些视力和OCT结果。
使用OCT引导的玻璃体内注射雷珠单抗可变剂量方案的PrONTO研究产生的视力结果与III期临床研究的结果相当，但所需的玻璃体内注射次数更少。
