Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration -: Twelve-month clinical outcomes
Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration -: Twelve-month clinical outcomes
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DOI：
10.1016/j.ophtha.2003.08.020
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发表时间：
2003-12-01
期刊：
影响因子：
13.7
通讯作者：
Beasley, C
中科院分区：
文献类型：
--
作者：
Russell, S;Boldt, HC;Beasley, C
目的：评价血管生成抑制剂醋酸阿奈可他与安慰剂相比治疗中心凹下脉络膜新生血管（CNV）的安全性和有效性。设计：对醋酸阿奈可他进行盲法、随机、安慰剂对照、平行评价（30 mg、15 mg和3 mg）对比安慰剂。参与者：入选并治疗了128例（128只眼）继发于年龄相关性黄斑变性的中心凹下CNV患者，80%（102/128）的眼睛在基线时主要表现为典型病变。方法：所有眼睛均接受了盲态研究药物或安慰剂的后巩膜贮库应用，如果设盲的研究者认为患者可能获益，则每隔6个月重新开始治疗。患者接受定期详细眼科检查（荧光素和吲哚菁绿色血管造影）、一般体格检查（心电图）和血液学/血清化学/尿分析。所有眼科和全身安全性数据由监督研究的独立安全委员会定期审查。主要结果测量：随着时间的推移和治疗组之间比较最小分辨率角（logMAR）视力和荧光素血管造影病变特征的最佳校正对数。第12个月时，在3项临床疗效指标方面，以6个月间隔给药的醋酸阿奈可他（15 mg）在统计学上上级安慰剂：2016 - 05 - 23 01：01：01 01：01 01：01 02：01 02：01 03：01 03：01 04：03 04：03 04：03 04：05 04：05 05 05：05 05 06：05
Purpose: To evaluate safety and efficacy of the angiostatic agent anecortave acetate, compared with a placebo, for treatment of subfoveal choroidal neovascularization (CNV).Design: Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo.Participants: There were 128 eyes of 128 patients with subfoveal CNV secondary to age-related macular degeneration who were enrolled and treated, with 80% (102/128) of eyes presenting with predominantly classic lesions at baseline.Methods: All eyes received a posterior juxtascleral depot application of masked study medication or a placebo, with retreatment at 6-month intervals if the masked investigator believed the patient could benefit. Patients received periodic detailed ophthalmic examinations with both fluorescein and indocyanine green angiography, general physical examinations with electrocardiograms, and hematology/serum chemistry/urinalysis. All ophthalmic and systemic safety data were periodically reviewed by the Independent Safety Committee overseeing the study.Main Outcome Measures: Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups.Results: At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision (P = 0.0131), stabilization of vision (