The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48
研究概览
简要总结
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.
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
- Triple (Participant, Care Provider, 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 2 diabetes
- •18 years or older
- •Hemoglobin A1c (HbA1c) less than or equal to 11%
- •Mild to very severe non-proliferative diabetic retinopathy in the study eye
- •Clinically significant macular edema in the study eye not within 100 microns of center of macula
排除标准
- •Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
- •Glaucoma in the study eye
- •Unstable cardiovascular disease
- •Major surgery within past 3 months
- •Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
研究组 & 干预措施
Ruboxistaurin
32 mg taken orally daily for up to 48 months
干预措施: Ruboxistaurin (Drug)
Placebo
Taken orally daily for up to 48 months
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48
时间窗: Baseline through 48 months
SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. 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).
次要结局
- Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24(Baseline through 24 months)
- Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula(Baseline, 24 months)
- Time to Focal Photocoagulation(Baseline through 48 months)
- Change From Baseline to Month 24 in Contrast Sensitivity(Baseline, 24 months)
- Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula(Baseline, up to 24 months)
- Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24(Baseline through 24 months)
- Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24(Baseline through 24 months)
- Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24(Baseline through 24 months)