NCT00239928已完成2 期
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Summary of Adverse Events
研究概览
简要总结
This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After completion of the preceding study (A5751010)
排除标准
- •Serious heart, kidney and/or liver disease
- •Diabetic retinopathy
研究组 & 干预措施
EYE001
Experimental
干预措施: pegaptanib sodium (Drug)
结局指标
主要结局
Summary of Adverse Events
时间窗: Week 54 (initiation of A5751015 study) up to Week 198
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
次要结局
- Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point(Week 0 (baseline), every 18 weeks from Week 54 up to Week 198)
- Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point(Weeks 54, every 18 weeks from Week 54 up to Week 198)
- Number of Responders(Week 0 (baseline), every 18 weeks from Week 54 up to Week 198)
- Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)(Week 0 (baseline), every 18 weeks from Week 54 up to Week 198)
- Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)(Week 0 (baseline), every 18 weeks from Week 54 up to Week 198)
- Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)(Week 0 (baseline), every 18 weeks from Week 54 up to Week 198)
研究者
研究点 (1)
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