NCT01100307已完成3 期
A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 243
- 试验地点
- 43
- 主要终点
- Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
研究概览
简要总结
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
详细描述
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I, or Type II diabetic subjects
- •Subjects must have macular edema that involves the center field of the macula
- •Foveal thickness of at least 250 μm
- •Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
排除标准
- •Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
- •HbA1C level >12% or recent signs of uncontrolled diabetes
- •Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
研究组 & 干预措施
sham injection
Sham Comparator
干预措施: sham injection (Other)
pegaptanib sodium
Experimental
干预措施: pegaptanib sodium (Drug)
结局指标
主要结局
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
时间窗: Baseline and Week 24
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
- Change From Baseline in Visual Acuity (VA): Double Masked Phase(Baseline, Weeks 6, 12, 18, and 24)
- Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase(Up to 24 weeks)
- Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase(Baseline and Week 54)
- Change From Baseline in Visual Acuity (VA): Open Phase(Baseline, Weeks 30, 36, 42, 48 and 54)
- Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase(Weeks 24 to 54)
研究者
研究点 (43)
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