Department of Ophthalmology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.
Acta Ophthalmol. 2012 Feb;90(1):61-7. doi: 10.1111/j.1755-3768.2009.01841.x. Epub 2010 Mar 16.
To compare the outcomes of treatment with intravitreal bevacizumab alone (BEVA group) or in combination with photodynamic therapy (PDT) (COMB group), in patients aged at least 50 years with neovascular maculopathy.
Forty-one patients with neovascular age-related macular degeneration (AMD) (n = 31) or polypoidal choroidal vasculopathy (PCV) (n = 10) were randomized to either the BEVA group (n = 18) or the COMB group (n = 23). A total of three intravitreal bevacizumab injections (1.25 mg/0.05 ml) were given at 6-week intervals. In the COMB group, PDT was included near the time of one injection. Patients underwent best-corrected visual acuity (BCVA) measurement and optical coherence tomography (OCT) at every visit. Fluorescein angiography and indocyanine green angiography were repeated every 3 months.
Overall BCVA (p = 0.001) and central foveal thickness (CFT) (p < 0.001) measured by OCT improved significantly at 12 months, and there was no between-group difference in BCVA or CFT between the BEVA and COMB groups. Whereas AMD patients showed significant improvement in BCVA (p = 0.001) and CFT (p = 0.004), PCV patients failed to improve. The effect of bevacizumab alone on neovascular AMD was similar to that of combination therapy, when measured by both BCVA and CFT. The total number of bevacizumab injections was not reduced when PDT was given, either among all patients or in a subgroup of naïve patients (p > 0.05). No serious complication was noted.
The results of our 12-month prospective study indicate that intravitreal bevacizumab alone has similar efficacy and safety to bevacizumab plus PDT for treatment of patients with neovascular AMD, even treatment-naïve patients. The addition of PDT did not assist in reducing the required total number of bevacizumab injections.
比较玻璃体腔内单独使用贝伐单抗(BVA 组)或联合光动力疗法(PDT)(联合组)治疗年龄至少 50 岁的新生血管性黄斑病变患者的结果。
41 例新生血管性年龄相关性黄斑变性(AMD)(n = 31)或息肉状脉络膜血管病变(PCV)(n = 10)患者随机分为 BVA 组(n = 18)或联合组(n = 23)。每 6 周给予 3 次玻璃体腔内贝伐单抗注射(1.25mg/0.05ml)。在联合组中,在接近一次注射时加入 PDT。患者每次就诊时均行最佳矫正视力(BCVA)测量和光学相干断层扫描(OCT)。每 3 个月重复进行荧光素血管造影和吲哚青绿血管造影。
总体 BCVA(p = 0.001)和 OCT 测量的中心凹视网膜厚度(CFT)(p < 0.001)在 12 个月时显著改善,BVA 和 CFT 两组之间无组间差异。AMD 患者的 BCVA(p = 0.001)和 CFT(p = 0.004)显著改善,而 PCV 患者则未改善。BVA 和 CFT 均显示,单独使用贝伐单抗治疗新生血管性 AMD 的效果与联合治疗相似。无论在所有患者中还是在一组初治患者中(p > 0.05),给予 PDT 后,贝伐单抗的总注射次数并未减少。未观察到严重并发症。
我们为期 12 个月的前瞻性研究结果表明,玻璃体腔内单独使用贝伐单抗治疗新生血管性 AMD 的疗效和安全性与贝伐单抗联合 PDT 相似,甚至对初治患者也是如此。PDT 的加入并不能帮助减少所需的贝伐单抗总注射次数。