A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions
研究概览
简要总结
The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.
详细描述
A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
- •Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye
排除标准
- •Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
- •Subjects having subfoveal fibrosis/ scar or atrophy representing > 25% of the total lesion size
研究组 & 干预措施
Open Label
干预措施: Pegaptanib Sodium 0.3 mg (Drug)
结局指标
主要结局
Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions
时间窗: Baseline through Week 54
The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing \>=30 letters or \<15 letters from Baseline, gaining \>=0 or \>=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.
次要结局
- Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions(Baseline through Week 102, Week 54 through Week 102)
- Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions(Baseline through Week 54, Baseline through Week 102)
- Mean Change in Reading Speed(Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102)
- Mean Change From Baseline in Contrast Sensitivity(Baseline through Week 54, Baseline through Week 102)
- Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score(Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102)
- Mean Change in Euro QoL Questionnaire (EQ-5D) Score(Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102)