Department of Ophthalmology, Odense University Hospital, Denmark.
Acta Ophthalmol. 2009 Nov;87(7):714-9. doi: 10.1111/j.1755-3768.2008.01346.x. Epub 2008 Dec 16.
To report the effects of intravitreal bevacizumab (Avastin) in treatment-naive patients with exudative age-related macular degeneration (ARMD) assessed by visual acuity (VA), optical coherence tomography (OCT) and contrast sensitivity.
A prospective, uncontrolled, pilot study of 26 eyes of 26 patients, all previously treatment-naive to photodynamic therapy, argon laser or anti-vascular endothelial growth factor (VEGF), were treated with one or more intravitreal injections of 1.25 mg bevacizumab. Of the 26 patients, 15 (57.7%) had occult choroidal neovascularization (CNV), 6 (23.1%) had predominantly classic CNV and 5 (19.2%) had minimally classic CNV. Ophthalmic outcome measures included changes in standardized Early Treatment Diabetic Research Study (ETDRS) VA, contrast sensitivity and OCT. The patients were examined at baseline and 1 week, 6 weeks, 3 months and 6 months after the first injection. Re-treatment was given on an 'as needed' basis.
Twenty-four eyes of 24 patients completed 6 months of follow-up. Two patients chose to discontinue the study. Mean ETDRS VA score improved from 55 letters at baseline to 60 letters at 1 week (P < 0.01) and to 61 letters at 6 weeks (P < 0.01). No significant improvement in VA from baseline was found after 3 and 6 months. Patients with pigment epithelial detachment (PED) had a significantly worse outcome in VA at 6 months. Contrast sensitivity improved from baseline to 3 or 6 months, but this improvement was not statistically significant. Mean macular thickness decreased significantly from baseline to all follow-up examinations (P < 0.01).
Mean ETDRS VA improved significantly after 1 and 6 weeks; thereafter, it remained stable throughout the study period. Macular thickness improved significantly at all time points. The results indicate that 1.25 mg intravitreal bevacizumab is associated with functional as well as morphological improvement among treatment-naive ARMD patients.
通过视力(VA)、光学相干断层扫描(OCT)和对比敏感度评估初治渗出性年龄相关性黄斑变性(ARMD)患者玻璃体腔内注射贝伐单抗(Avastin)的疗效。
对 26 例(26 只眼)患者进行前瞻性、非对照、试点研究,所有患者均未曾接受过光动力疗法、氩激光或抗血管内皮生长因子(VEGF)治疗,接受了 1.25mg 贝伐单抗玻璃体腔内注射 1 次或多次。26 例患者中,隐匿性脉络膜新生血管(CNV)15 例(57.7%),典型 CNV 为主型 6 例(23.1%),微典型 CNV 5 例(19.2%)。眼部疗效评估指标包括标准化早期糖尿病视网膜病变研究(ETDRS)视力、对比敏感度和 OCT 的变化。患者于基线和首次注射后 1 周、6 周、3 个月和 6 个月接受检查。根据需要进行再治疗。
24 例(24 只眼)患者完成了 6 个月的随访。2 例患者选择退出研究。平均 ETDRS VA 评分从基线时的 55 个字母提高到 1 周时的 60 个字母(P<0.01)和 6 周时的 61 个字母(P<0.01)。3 个月和 6 个月时,VA 无明显改善。存在色素上皮脱离(PED)的患者 6 个月时 VA 结局明显较差。对比敏感度从基线提高到 3 个月或 6 个月,但无统计学意义。黄斑中心厚度从基线到所有随访检查均显著降低(P<0.01)。
1 周和 6 周后,平均 ETDRS VA 显著提高;此后,整个研究期间保持稳定。黄斑中心厚度在所有时间点均显著改善。结果表明,初治 ARMD 患者玻璃体腔内注射 1.25mg 贝伐单抗可改善视力和形态。