Parodi Maurizio Battaglia, Iacono Pierluigi, Kontadakis Dimitrios Stelyos, Zucchiatti Ilaria, Cascavilla Maria Lucia, Bandello Francesco
Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy.
Arch Ophthalmol. 2010 Sep;128(9):1100-3. doi: 10.1001/archophthalmol.2010.205.
To compare the effectiveness of photodynamic therapy (PDT) vs intravitreal bevacizumab injection in patients with subfoveal choroidal neovascularization (CNV) secondary to multifocal choroiditis (MC).
Patients affected by subfoveal CNV associated with MC referred for clinical evaluation from March 1, 2005, to July 31, 2008, were considered for this pilot randomized clinical trial. Twenty-seven patients were included in the study and followed up from March 15, 2005, through April 30, 2009. After randomization, patients receiving PDT were treated according to the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy protocol, whereas patients receiving intravitreal bevacizumab injection, after a loading phase of 3 monthly injections, were examined monthly and re-treated on the basis of detection of fluid on optical coherence tomography and/or leakage on fluorescein angiography.
The primary outcome measure was the 5- and 15-letter change on the Early Treatment of Diabetic Retinopathy Study charts at 12-month examinations compared with baseline. Secondary outcomes included central macular thickness changes.
Thirteen and 14 patients were randomized to PDT and bevacizumab treatment, respectively. At the 12-month examination, 5 of 14 eyes treated with bevacizumab and 0 of 13 eyes treated with PDT experienced a best-corrected visual acuity gain of greater than 3 lines (P = .04). Twelve eyes in the bevacizumab group and 6 eyes in the PDT group gained more than 1 line (P = .04). The central macular thickness showed a progressive reduction in both subgroups without a significant difference compared with the baseline values.
Greater beneficial effects can be achieved using intravitreal bevacizumab injection rather than PDT for the treatment of subfoveal CNV secondary to MC. Larger multicenter investigations are needed to confirm our preliminary results. Application to Clinical Practice Currently, there is no precise indication regarding the best therapeutic approach to subfoveal CNV secondary to MC. This investigation was designed to verify whether intravitreal bevacizumab injection has a more beneficial effect with respect to PDT.
比较光动力疗法(PDT)与玻璃体内注射贝伐单抗治疗多灶性脉络膜炎(MC)继发的黄斑下脉络膜新生血管(CNV)患者的疗效。
本前瞻性随机临床试验纳入了2005年3月1日至2008年7月31日因MC相关的黄斑下CNV前来进行临床评估的患者。27例患者纳入研究,随访时间为2005年3月15日至2009年4月30日。随机分组后,接受PDT治疗的患者按照光动力疗法治疗年龄相关性黄斑变性方案进行治疗,而接受玻璃体内注射贝伐单抗的患者在3个月每月注射的负荷期后,每月进行检查,并根据光学相干断层扫描检测到的液体积聚和/或荧光素血管造影显示的渗漏情况进行再次治疗。
主要观察指标为与基线相比,在12个月检查时糖尿病视网膜病变早期治疗研究图表上字母变化5个和15个。次要观察指标包括黄斑中心厚度变化。
分别有13例和14例患者随机接受PDT和贝伐单抗治疗。在12个月检查时,接受贝伐单抗治疗的14只眼中有5只最佳矫正视力提高超过3行,而接受PDT治疗的13只眼中无1只视力提高超过3行(P = 0.04)。贝伐单抗组12只眼和PDT组6只眼视力提高超过1行(P = 0.04)。两个亚组的黄斑中心厚度均呈逐渐降低,与基线值相比无显著差异。
对于治疗MC继发的黄斑下CNV,玻璃体内注射贝伐单抗比PDT能产生更大的有益效果。需要更大规模的多中心研究来证实我们的初步结果。应用于临床实践目前,对于MC继发的黄斑下CNV的最佳治疗方法尚无确切的指征。本研究旨在验证玻璃体内注射贝伐单抗相对于PDT是否具有更有益的效果。