Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 1
- 主要终点
- Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
研究概览
简要总结
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes
- •18 years or older
- •Non-clinically significant diabetic macular edema
- •Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
- •Relatively good vision (20/30 or better)
排除标准
- •Surgery or laser treatment in the study eye
- •Glaucoma in the study eye
- •Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
- •Liver disease, dialysis or renal transplant
研究组 & 干预措施
Placebo
QD oral for up to 36 months
干预措施: placebo (Drug)
Ruboxistaurin
32 milligrams (mg) once daily (QD) oral for up to 36 months
干预措施: ruboxistaurin (Drug)
结局指标
主要结局
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
时间窗: 6 Months through 36 Months
Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
时间窗: Baseline, 36 Months
The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.
次要结局
- Change From Baseline in Estimated Glomerular Filtration Rate(Baseline, 36 Months)
- First Occurrence of Focal/Grid Photocoagulation(Baseline through 36 Months)
- Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months(Baseline, 36 Months)
- Change From Baseline in Contrast Sensitivity by Pelli-Robson(Baseline, 36 Months)
- Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography(Baseline through 36 Months)
- Change From Baseline at Endpoint in Albumin/Creatinine Ratio(36 Months)
- Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months(36 Months)
- Number of Participants With Adverse Events(Baseline through 36 Months)