15 mg乙酸阿奈可他与光动力疗法治疗年龄相关性黄斑变性的中心凹下新生血管的比较研究  

Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration

作　　者：Slakter J.S. BochowT. D'Amico D.J. 王静波 

机构地区：[1]460 Park Avenue, New York, NY 10022, United States Dr.

出　　处：《世界核心医学期刊文摘（眼科学分册）》2006年第5期48-49,共2页Digest of the World Core Medical Journals:Ophthalmology

摘　　要：PURPOSE: To compare 1-year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy (PDT) with verteporfin in patients eligible for initial PDT treatment. Design: Prospective, masked, randomized, multicenter, parallel group, active control, noninferiority clinical trial. Participants: Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT. Methods: In the anecortave acetate group, the drug was administered under the Tenon’s capsule as a periocular posterior juxtascleral depot (PJD) at the beginning of the study and at month 6. Before the first administration of anecortave acetate, patients in this treatment group received a sham PDT treatment, and sham PDT treatments were repeated every 3 months if there was evidence of leakage on fluorescein angiography (FA). Patients assigned to PDT received up to 4 PDT treatments at 3-month intervals, as needed based upon FA, and a sham PJD procedure at the beginning of the study and at month 6. Best-corrected visual acuity was determined at baseline and all follow-up visits. Safety data were regularly reviewed by an independent safety committee. Main Outcome Measure: Percent responders (patients losing <3 lines of vision) at month 12. Results: Percent responders in the anecortave acetate and PDT groups were 45%and 49%, respectively (not statistically different, P=0.43). The confidence interval (CI) for the difference ranged from -13.2%favoring PDT to+5.6%favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was improved in patients for whom reflux was controlled and who were treated within the 6-month treatment window (57%vs. 49%; 95%CI,-4.3%favoring PDT to+21.7%favoring anecortave acetate). No serious adverse events related to the study drug were reported in either treatment group. Conclusions: The safety and efficacy outcomes in this study demonstrate that the benefits ofPurpose： To compare 1 - year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy （PDT） with verteporfin in patients eligible for initial PDT treatmenL Design： Prospective, masked, randomized, muhicenter, parallel group, active control, noninferiority clinical trial. Participants： Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT. Methods： In the anecortave acetate group, the drug was administered under the Tenon＇ s capsule as a periocular posterior juxtascleral depot （PJD） at the beginning of the study and at month 6. Before the first administration of anecortave acetate, patients in this treatment group received a sham PDT treatment, and sham PDT treatments were re leakage peated every 3 months if there was evidence of on fluorescein angiography （FA） .

关 键 词：中心凹下脉络膜新生血管 年龄相关性黄斑变性 光动力疗法 治疗组 乙酸 TENON囊 荧光血管造影 PDT 安全性 维替泊芬 

分 类 号：R773.4[医药卫生—眼科] R774.5[医药卫生—临床医学]