Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration - Phase II study results
Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration - Phase II study results
复制标题
DOI：
10.1016/s0161-6420(03)00085-x
复制
发表时间：
2003-05-01
期刊：
影响因子：
13.7
通讯作者：
Patel, S
中科院分区：
文献类型：
--
作者：
Fish, G;Haller, JA;Patel, S
用途：有证据表明，抗血管内皮生长因子（抗VEGF）治疗可能是有用的治疗眼部新生血管。一项IA期单次玻璃体内注射抗VEGF治疗继发于年龄相关性黄斑变性（AMD）的中心凹下脉络膜新生血管（CNV）患者的研究显示了良好的安全性。我们对继发于AMD的黄斑下CNV患者进行了II期多次注射抗VEGF治疗联合和不联合光动力治疗的研究，以确定多次注射治疗的安全性。设计：II期多次剂量安全性研究。参与者/方法：21例患者接受玻璃体内注射联合和不联合光动力治疗。主要结果测量：毒性和并发症的临床证据。结果：未发现药物相关严重不良事件。眼科评估显示，87.5%接受单独抗VEGF适体的患者在治疗后3个月显示稳定或改善的视力，并且在此期间，25%的眼睛在糖尿病视网膜病变研究的早期治疗表上显示3行或更大的视力改善。一个60%的3线增益在3个月的患者谁收到的抗VEGF适体和photodynamictherapy.Conclusions：抗VEGF治疗是一种有前途的治疗各种形式的眼新生血管，包括AMD。在该II期研究中，多次玻璃体内注射抗VEGF适体耐受良好。需要进一步的临床试验来证明抗VEGF治疗AMD的疗效和长期安全性。
Purpose: There is evidence to suggest that anti-vascular endothelial growth factor (anti-VEGF) therapy may be useful in treating ocular neovascularization. A phase IA single intravitreal injection study of anti-VEGF therapy for patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) revealed a good safety profile. We performed a phase II multiple injection study of anti-VEGF therapy with and without photodynamic therapy for patients with subfoveal CNV secondary to AMD to determine the safety profile of multiple injection therapy.Design: A phase II multiple-dose safety study.Participants/Methods: Twenty-one patients were treated with intravitreal injection with and without photodynamic therapy.Main Outcome Measures: Clinical evidence of toxicity and complications.Results: No drug-related serious adverse events were revealed. Ophthalmic evaluation revealed that 87.5% of patients who received the anti-VEGF aptamer alone showed stabilized or improved vision 3 months after treatment and that 25% of eyes demonstrated a 3 line or greater improvement in vision on the Early Treatment of Diabetic Retinopathy Study chart during this period. A 60% 3 line gain at 3 months was noted in patients who received both the anti-VEGF aptamer and photodynamic therapy.Conclusions: Anti-VEGF therapy is a promising treatment for various forms of ocular neovascularization, including AMD. Multiple intravitreal injections of the anti-VEGF aptamer were well tolerated in this phase II study. Further clinical trials are necessary to demonstrate the efficacy and long-term safety of anti-VEGF therapy for AMD.