Avery Robert L, Pieramici Dante J, Rabena Melvin D, Castellarin Alessandro A, Nasir Ma'an A, Giust Matthew J
California Retina Consultants, Santa Barbara, California 93103, USA.
Ophthalmology. 2006 Mar;113(3):363-372.e5. doi: 10.1016/j.ophtha.2005.11.019. Epub 2006 Feb 3.
To report the short-term safety, biologic effect, and a possible mechanism of action of intravitreal bevacizumab in patients with neovascular age-related macular degeneration (AMD).
Interventional, consecutive, retrospective case series.
Eighty-one eyes of 79 patients with subfoveal neovascular AMD.
Patients received intravitreal bevacizumab (1.25 mg) on a monthly basis until macular edema, subretinal fluid (SRF), and/or pigment epithelial detachment (PED) resolved. Ophthalmic evaluations included nonstandardized Snellen visual acuity (VA), complete ophthalmic examination, fluorescein angiography, and optical coherence tomography (OCT).
Assessments of safety, changes in Snellen VA, OCT retinal thickness, and angiographic lesion characteristics were performed.
No significant ocular or systemic side effects were observed. Most patients (55%) had a reduction of >10% of baseline retinal thickness at 1 week after the injection. At 4 weeks after injection, 30 of 81 eyes demonstrated complete resolution of retinal edema, SRF, and PEDs. Of the 51 eyes with 8 weeks' follow-up, 25 had complete resolution of retinal thickening, SRF, and PEDs. At 1, 4, 8,and 12 weeks, the mean retinal thickness of the central 1 mm was decreased by 61, 92, 89, and 67 mum, respectively (P<0.0001 for 1, 4, and 8 weeks and P<0.01 for 12 weeks). At 4 and 8 weeks, mean VA improved from 20/200 to 20/125 (P<0.0001). Median vision improved from 20/200 to 20/80(-) at 4 weeks and from 20/200 to 20/80 at 8 weeks.
Short-term results suggest that intravitreal bevacizumab (1.25 mg) is well tolerated and associated with improvement in VA, decreased retinal thickness by OCT, and reduction in angiographic leakage in most patients, the majority of whom had previous treatment with photodynamic therapy and/or pegaptanib. Further evaluation of intravitreal bevacizumab for the treatment of choroidal neovascularization is warranted.
报告玻璃体内注射贝伐单抗治疗新生血管性年龄相关性黄斑变性(AMD)患者的短期安全性、生物学效应及可能的作用机制。
干预性、连续性、回顾性病例系列研究。
79例中心凹下新生血管性AMD患者的81只眼。
患者每月接受一次玻璃体内注射贝伐单抗(1.25mg),直至黄斑水肿、视网膜下液(SRF)和/或色素上皮脱离(PED)消退。眼科评估包括非标准化的斯内伦视力(VA)、全面的眼科检查、荧光素血管造影和光学相干断层扫描(OCT)。
进行安全性评估、斯内伦VA变化、OCT视网膜厚度变化及血管造影病变特征评估。
未观察到明显的眼部或全身副作用。大多数患者(55%)在注射后1周时视网膜厚度较基线减少>10%。注射后4周,81只眼中有30只眼的视网膜水肿、SRF和PED完全消退。在51只随访8周的眼中,25只眼的视网膜增厚、SRF和PED完全消退。在1、4、8和12周时,中心1mm处的平均视网膜厚度分别减少了61、92、89和67μm(1、4和8周时P<0.0001,12周时P<0.01)。在4周和8周时,平均视力从20/200提高到20/125(P<0.0001)。视力中位数在4周时从20/200提高到20/80(-),在8周时从20/200提高到20/80。
短期结果表明,玻璃体内注射贝伐单抗(1.25mg)耐受性良好,多数患者视力提高、OCT显示视网膜厚度降低、血管造影渗漏减少,其中大多数患者既往接受过光动力疗法和/或培加他尼治疗。有必要进一步评估玻璃体内注射贝伐单抗治疗脉络膜新生血管的疗效。