A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 563
- 试验地点
- 132
- 主要终点
- Worsening of diabetic retinopathy
研究概览
简要总结
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and < 80 years.
- •Type 1 or type 2 diabetes.
- •At least one eye with the following:
- •Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
- •Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study.
- •If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)
排除标准
- •Eye-level exclusion criteria (the eye is ineligible if any of the following is met):
- •Current CI-DME based on clinical exam or OCT central subfield thickness (CST)
- •Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
- •Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
- •Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
- •History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
- •Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):
- •Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2
研究组 & 干预措施
Fenofibrate 160-mg
干预措施: Fenofibrate (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Worsening of diabetic retinopathy
时间窗: 6- years
Defined as * 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs. * Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography. * Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
次要结局
- Visual acuity loss from any cause(6 years)
- Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy(6 years)
- Development of CI-DME(6 years)
- Development of center-involved diabetic macular edema with vision loss(6 years)