Lazic Ratimir, Gabric Nikica
Eye Clinic Svjetlost, Bukovacka 27, 10000 Zagreb, Croatia.
Graefes Arch Clin Exp Ophthalmol. 2007 Jan;245(1):68-73. doi: 10.1007/s00417-006-0466-4. Epub 2006 Nov 18.
Anti-vascular endothelial growth factor (anti-VEGF) agents have been shown to be effective in the treatment of neovascular age-related macular degeneration (AMD). Efficacy and safety of intravitreally administered bevacizumab (Avastin), a humanized monoclonal anti-VEGF, was assessed in minimally classic and occult subfoveal choroidal neovascularization (CNV) due to AMD.
A prospective interventional study was carried out. Bevacizumab (1.25 mg) was administered intravitreally on a 6-week basis until macular edema, subretinal fluid, and/or pigment epithelial detachment had resolved. Administration was repeated in case of relapse. Ophthalmic evaluations included a complete ophthalmic examination, measurement of the visual acuity (VA), optical coherence tomography, and fluorescein angiography. Main outcome measures were the changes between baseline and last follow-up visit in best-corrected VA, central foveal thickness (CFT) and total macular volume (TMV).
From 102 patients [mean age (range) 74.8 (61-85) years], 102 eyes were included. Median (range) duration of follow-up was 18 (6-24) weeks. Statistically significant changes from baseline were observed in best-corrected VA [increase of 1.29 lines (P=0.001)], CFT [reduction of 56 microm (P=0.01)] and TMV [reduction of 0.80 mm(3) (P<0.0001)]. Positive results were obtained in 65/102 (64%) patients after two to three injections as a mean. In a substantial proportion of patients (38%) followed up for at least 18 weeks, recurrence of leakage requiring additional injections was observed. Treatment was well tolerated; two pigment epithelium rips and ten posterior vitreous detachments were reported.
Short-term results suggest that intravitreally administered bevacizumab (Avastin) is effective in minimally classic and occult CNV due to AMD. Significant improvements in VA, CFT and TMV were obtained and maintained during follow-up. In some patients, however, recurrence of leakage requiring additional intravitreal injection occurred. Maintenance of the effect of bevacizumab and its safety after repeated and prolonged administration have to be investigated in well-controlled studies.
抗血管内皮生长因子（anti-VEGF）药物已被证明在治疗新生血管性年龄相关性黄斑变性（AMD）方面有效。评估了玻璃体内注射人源化单克隆抗VEGF药物贝伐单抗（阿瓦斯汀）治疗AMD所致的最小经典型和隐匿性黄斑下脉络膜新生血管（CNV）的疗效和安全性。
开展一项前瞻性干预性研究。每6周玻璃体内注射一次贝伐单抗（1.25毫克），直至黄斑水肿、视网膜下液和/或色素上皮脱离消退。复发时重复给药。眼科评估包括全面的眼科检查、视力（VA）测量、光学相干断层扫描和荧光素血管造影。主要结局指标是最佳矫正视力、中心凹厚度（CFT）和黄斑总体积（TMV）在基线和最后一次随访之间的变化。
纳入102例患者[平均年龄（范围）74.8（61 - 85）岁]的102只眼。中位（范围）随访时间为18（6 - 24）周。观察到最佳矫正视力[提高1.29行（P = 0.001）]、CFT[降低56微米（P = 0.01）]和TMV[降低0.80立方毫米（P < 0.0001）]与基线相比有统计学显著变化。平均两到三次注射后，65/102（64%）例患者获得阳性结果。在相当比例（38%）随访至少18周的患者中，观察到渗漏复发需要额外注射。治疗耐受性良好；报告了2例色素上皮撕裂和10例玻璃体后脱离。
短期结果表明，玻璃体内注射贝伐单抗（阿瓦斯汀）治疗AMD所致的最小经典型和隐匿性CNV有效。随访期间，VA、CFT和TMV有显著改善并得以维持。然而，部分患者出现渗漏复发需要额外玻璃体内注射。必须在严格对照研究中调查贝伐单抗重复和长期给药后的疗效维持情况及其安全性。
