Pedersen Robert, Soliman Wael, Lund-Andersen Henrik, Larsen Michael
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark.
Acta Ophthalmol Scand. 2007 Aug;85(5):526-33. doi: 10.1111/j.1600-0420.2007.00895.x. Epub 2007 May 18.
This study aimed to assess the pharmacodynamic profile of intravitreal bevacizumab in relation to best corrected visual acuity (BCVA), foveal thickness, and other aspects of macular morphology after intravitreal injection of bevacizumab in eyes with subretinal choroidal neovascularization (CNV).
A retrospective observational, uncontrolled case series including 26 eyes in 25 patients followed for up to 6 months after intravitreal injection of bevacizumab 1 mg repeated as deemed necessary after monthly assessments by biomicroscopy, optical coherence tomography, colour fundus photography, fluorescein angiography and BCVA determination. At follow-up, cases were classified by morphological treatment response (reduction or elimination of pathological neovascular leakage, retinal thickening or serous retinal detachment) or absence of response (deterioration or lack of improvement). Primary disease entities included age-related macular degeneration (22 eyes, four of which had evidence of retinal angiomatous proliferation), idiopathic peripapillary neovascularization (one eye), and angioid streaks (three eyes in two patients).
One month after the first injection, apparent morphological improvement was observed in 24/26 eyes and mean BCVA had improved by 3.1 +/- 7.8 letters (p = 0.05). Of these 24 responders, which included all primary diagnoses, 11 (46%) demonstrated BCVA improvement of >or= 5 letters. The two non-responders (7.7%) had lost > 3 lines of vision at 2 months follow-up. Overall, 18 eyes completed 6 months follow-up, with a mean BCVA improvement of 0.5 +/- 12.7 letters, and 22 eyes completed 3 months follow-up, with a mean BCVA improvement of 2.0 +/- 11.0 letters. Two months after the first injection, 11 (46%) of the 24 responders demonstrated signs of recurrent CNV activity, defined as decreased BCVA and/or increased retinal thickness and/or fluorescein angiographic CNV leakage. No serious drug-related adverse events were observed during the course of the study.
Overall mean BCVA remained stable throughout the study. Morphological signs of reduced CNV activity were seen in the majority of eyes at 2-4 weeks after intravitreal bevacizumab injection. Half the responders showed signs of renewed CNV activity at 2 months after their first injection. All first-injection responders were also second-injection responders.
本研究旨在评估玻璃体内注射贝伐单抗治疗视网膜下脉络膜新生血管(CNV)眼后,其药效学特征与最佳矫正视力(BCVA)、黄斑中心凹厚度及黄斑形态其他方面的关系。
一项回顾性观察性、非对照病例系列研究,纳入25例患者的26只眼,在玻璃体内注射1mg贝伐单抗后随访长达6个月,每月通过生物显微镜检查、光学相干断层扫描、彩色眼底照相、荧光素血管造影及BCVA测定进行评估,必要时重复注射。随访时,根据形态学治疗反应(病理性新生血管渗漏、视网膜增厚或浆液性视网膜脱离减轻或消除)或无反应(病情恶化或无改善)对病例进行分类。主要疾病类型包括年龄相关性黄斑变性(22只眼,其中4只眼有视网膜血管瘤样增生证据)、特发性视乳头周围新生血管形成(1只眼)和血管样条纹(2例患者中的3只眼)。
首次注射后1个月,26只眼中有24只眼出现明显的形态学改善,平均BCVA提高了3.1±7.8个字母(p = 0.05)。在这24例有反应者中,包括所有主要诊断类型,11例(46%)的BCVA提高了≥5个字母。2例无反应者(7.7%)在随访2个月时视力下降超过3行。总体而言,18只眼完成了6个月的随访,平均BCVA提高了0.5±12.7个字母,22只眼完成了3个月的随访,平均BCVA提高了2.0±11.0个字母。首次注射后2个月,24例有反应者中有11例(46%)出现CNV复发活动迹象,定义为BCVA下降和/或视网膜厚度增加和/或荧光素血管造影显示CNV渗漏。研究过程中未观察到严重的药物相关不良事件。
在整个研究过程中,总体平均BCVA保持稳定。玻璃体内注射贝伐单抗后2 - 4周,大多数眼中可见CNV活动减少的形态学迹象。一半的有反应者在首次注射后2个月出现CNV复发活动迹象。所有首次注射有反应者也是第二次注射有反应者。