Parodi Maurizio Battaglia, Iacono Pierluigi, Papayannis Alexandros, Sheth Saumil, Bandello Francesco
Department of Ophthalmology, University of Udine, Udine, Italy.
Arch Ophthalmol. 2010 Apr;128(4):437-42. doi: 10.1001/archophthalmol.2009.408. Epub 2010 Feb 8.
To compare the effects on visual acuity of laser treatment (LT), photodynamic therapy (PDT) with verteporfin, and intravitreal bevacizumab treatment in patients with juxtafoveal choroidal neovascularization secondary to pathologic myopia.
This prospective randomized clinical investigation enrolled 54 patients, who were divided into 3 groups receiving PDT, LT, or intravitreal bevacizumab treatment. The anti-vascular endothelial growth factor group received 1.25 mg of intravitreal bevacizumab at baseline; retreatment was performed if persistent intraretinal or subretinal fluid evaluated on optical coherence tomography or if choroidal neovascularization progression was detected on fluorescein angiography. The PDT group received treatment following the Verteporfin in Photodynamic Therapy Study Group guidelines. The LT group was submitted to direct LT and received PDT treatment if subfoveal recurrence or progression was detected on fluorescein angiography. A change in best-corrected visual acuity was the primary outcome.
The mean best-corrected visual acuity in the PDT group decreased from 0.52 logMAR (SD, 0.24 logMAR) at baseline to 0.72 logMAR (SD, 0.25 logMAR) at the end of the study (P = .002). The LT group showed substantial stabilization from mean baseline visual acuity (mean, 0.45 logMAR [SD, 0.27 logMAR]) to the 24-month (mean, 0.56 logMAR [SD, 0.34 logMAR) examination values. The mean best-corrected visual acuity in the anti-vascular endothelial growth factor group increased from 0.6 logMAR (SD, 0.3 logMAR) at baseline to 0.42 logMAR (SD, 0.35 logMAR) at the end of the study (P = .006).
Overall, bevacizumab treatment offers the best functional results during a 2-year follow-up. In view of the small size of the sample in this study and the relatively low frequency of juxtafoveal choroidal neovascularization secondary to pathologic myopia, a multicentric clinical trial is necessary to validate our results.
比较激光治疗(LT)、维替泊芬光动力疗法(PDT)和玻璃体内注射贝伐单抗治疗对病理性近视继发的黄斑旁脉络膜新生血管患者视力的影响。
这项前瞻性随机临床研究纳入了54例患者,他们被分为3组,分别接受PDT、LT或玻璃体内注射贝伐单抗治疗。抗血管内皮生长因子组在基线时接受1.25mg玻璃体内贝伐单抗治疗;如果光学相干断层扫描评估发现持续性视网膜内或视网膜下液,或荧光素血管造影检测到脉络膜新生血管进展,则进行再次治疗。PDT组按照光动力疗法研究组的维替泊芬指南进行治疗。LT组接受直接LT治疗,如果荧光素血管造影检测到黄斑下复发或进展,则接受PDT治疗。最佳矫正视力的变化是主要结局。
PDT组的平均最佳矫正视力从基线时的0.52 logMAR(标准差,0.24 logMAR)降至研究结束时的0.72 logMAR(标准差,0.25 logMAR)(P = 0.002)。LT组从平均基线视力(平均,0.45 logMAR [标准差,0.27 logMAR])到24个月时(平均,0.56 logMAR [标准差,0.34 logMAR])的检查值显示出显著稳定。抗血管内皮生长因子组的平均最佳矫正视力从基线时的0.6 logMAR(标准差,0.3 logMAR)增加到研究结束时的0.42 logMAR(标准差,0.35 logMAR)(P = 0.006)。
总体而言,在2年的随访期间,贝伐单抗治疗提供了最佳的功能结果。鉴于本研究样本量较小以及病理性近视继发的黄斑旁脉络膜新生血管发生率相对较低,有必要进行多中心临床试验来验证我们的结果。