NCT00683176已完成2 期
Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study
Abbott Products21 个研究点 分布在 10 个国家目标入组 110 人开始时间: 2008年9月最近更新:
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
- 入组人数
- 110
- 试验地点
- 21
- 主要终点
- Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
研究概览
简要总结
The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
干预措施: Choline Fenofibrate (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
时间窗: 12 months
次要结局
- OCT variables (Retinal Thickness, Retinal thickening)(12 months)
- ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema(12 months)
- Lipids(12 months)
- SBP/DBP, Urinary albumin excretion rate(12 months)
研究者
研究点 (21)
Loading locations...
相似试验
招募中
4 期
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined DyslipidemiaAtherosclerosisDyslipidemiaDiabetes Mellitus, Type 2NCT05365425Seoul National University Bundang Hospital56
进行中（未招募）
不适用
Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized StudyDiabetic macular edemaMedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edemaEUCTR2008-001064-37-DKFournier Laboratories Ireland106
进行中（未招募）
不适用
Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized StudyDiabetic macular edemaMedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edemaEUCTR2008-001064-37-CZFournier Laboratories Ireland (FLI)106
进行中（未招募）
不适用
Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized StudyDiabetic macular edemaMedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edemaEUCTR2008-001064-37-HUFournier Laboratories Ireland106
进行中（未招募）
1 期
Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized StudyDiabetic macular edemaMedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edemaEUCTR2008-001064-37-NLFournier Laboratories Ireland106