NCT00605280已完成2 期
A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
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
- 317
- 试验地点
- 1
- 主要终点
- Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
研究概览
简要总结
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •macular edema associated with diabetes
- •visual acuity between 20/50 and 20/200
排除标准
- •recent laser therapy in the eye
- •recent signs of uncontrolled diabetes
- •blood pressure worse than 160/100
- •severe cardiac disease
研究组 & 干预措施
Sham Control
Sham Comparator
干预措施: Standard of Care (Drug)
Macugen
Experimental
干预措施: Macugen (Drug)
结局指标
主要结局
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
时间窗: Baseline, Year 1
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
次要结局
- Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years(Baseline, Year 2)
- Change From Baseline in Mean VA Score at 2 Years(Baseline, Year 2)
- Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year(Baseline, Year 1)
- Number of Participants Requiring Focal or Grid Laser Treatment During Year 2(2 years)
- Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years(Baseline, Year 2)
- Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year(Baseline, Year 1)
- Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year(Baseline, Year 1)
- Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years(Baseline, Year 2)
- Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years(Baseline, Year 2)
- Number of Participants Requiring Focal or Grid Laser Treatment During Year 1(1 year)
- Change From Baseline in Mean VA Score at 1 Year(Baseline, Year 1)
研究者
研究点 (1)
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