NCT00619229终止3 期
Confirmatory, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Dry Age-related Macular Degeneration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 37
- 主要终点
- Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
研究概览
简要总结
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
详细描述
Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects older than 50 years of age.
- •Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning geographic atrophy in one eye
- •Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts
排除标准
- •Dry AMD AREDS category 3 or 4 in both eyes
- •Wet AMD in at least one eye
- •Detachment of the pigmentary epithelium
- •Diabetic retinopathy
- •Medical history of retinal vein occlusion
- •Cataract surgery during the study
- •High myopia (< -6 dpt) with pathological findings of the retina
- •Medical history of any opthalmic surgery with complications
- •Medical history of cataract surgery without complications within the last 12 weeks
- •Medical history of vitrectomy
- •AREDS medication within the last 2 days
- •Opthalmologic dietary supplements within the last 2 days
- •Medical history of retinal hemorrhage
- •Cardiac failure (NYHA grade II or higher)
- •Inadequately controlled coronary heart disease or cardiac arrhythmia
- •Subject has a medical history and/or suspicion of pulmonary edema or pulmonary infiltration
- •Subject has a peripheral edema
- •Myocardial infarction within 6 months prior to enrollment
- •Subject has renal insufficiency, compensated retention (creatinine > 1,5 mg/dL)
- •Subject has known existing malignant disease
- •Severe chronic obstructive pulmonary disease
- •Subject has a venoocclusive lung disease
- •Known hepatic disease
- •Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
- •Subject has upper grade cardiac valvular disorders
- •Pregnancy or lactation period
- •Known hypersensitivity to PGE1 or to any component of the trial medication
- •Subject has a history of chronic alcohol or drug abuse within the past 2 years
- •Subject has known lactose intolerance
- •Poor general state of health or other criteria
- •Subject has other serious illness
- •Laboratory values outside the normal range unless considered not clinically relevant by the investigator
研究组 & 干预措施
Alprostadil
Experimental
Alprostadil
干预措施: Alprostadil (prostaglandin E1) (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
时间窗: From baseline to 3 months
Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.
次要结局
- The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline(From baseline to time immediately after intervention)
- The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline(From baseline to 6 months)
- Progression of the Dry Age-related Macular Degeneration(From baseline to 6 months)
- The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline(From baseline to 6 months)
- Development of a Wet Age-related Macular Degeneration(From baseline to 6 months)
- The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline(From baseline to time immediately after intervention)
- The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline(From baseline to 3 months)
- The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline(From baseline to 6 months)
- The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline(From baseline to time immediately after intervention)
- The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline(From baseline to 3 months)
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