Phase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 685
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period
研究概览
简要总结
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
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
- 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 mellitus
- •18 years or older
- •Meet specific requirements for diabetic retinopathy
- •Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
- •Hemoglobin A1c (HbA1C) ≤13.0%
排除标准
- •History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
- •Investigators, site personnel directly affiliated with the study and their families
- •Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
- •Presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study
- •Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
研究组 & 干预措施
Ruboxistaurin
干预措施: ruboxistaurin (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period
时间窗: Baseline through 36 months
SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) \* 100.
次要结局
- Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)(Baseline through 36 months)
- Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire(Baseline, up to 36 months)
- Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)(Baseline through 36 months)
- Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)(Baseline, up to 36 months)