Levodopa for Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- ERG with dim flash stimuli
研究概览
简要总结
The purpose of this study is to determine optimum dosing strategies of levodopa and determine the physiologic mechanisms that provide the therapeutic response to restore abnormalities in the electrical conductivity of the retina in people with diabetes and no clinically visible retinopathy.
详细描述
This study is investigating the optimal timing of using levodopa in reducing damage in the retina from diabetes mellitus. Adult subjects will be recruited from the Atlanta VA Eye clinic and randomized to one of four arms: placebo, levodopa every other day, levodopa daily, or levodopa twice daily. Each group include participants that will receive treatment for 6 months with eye exams and testing conducted at baseline, 3 month, and 6 month visits. Testing at the visits includes electroretinograms, fundus photography, optical coherence tomography with angiography, and HbA1c serology. Veterans will sign the consent, in-person prior to beginning study activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Masking will be applied to diabetic participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with diabetes mellitus
排除标准
- •taking dopamine effecting drugs
- •have a pituitary tumor
- •psychosis, Parkinson's disease
- •cognitive deficits
- •confounding ocular disease
- •Control Participants:
- •Non-diabetic participants with no visual problems to create control measurements.
研究组 & 干预措施
Placebo
Diabetic participants will be instructed to take the oral placebo daily with a meal for 6 months.
干预措施: Placebo (Drug)
Levodopa every other day
Diabetic participants will be instructed to take the levodopa every other day with a meal for 6 months.
干预措施: Levodopa (Drug)
Levodopa once per day
Diabetic participants will be instructed to take the oral levodopa daily with a meal for 6 months..
干预措施: Levodopa (Drug)
Levodopa twice per day
Diabetic participants in the twice per day group will be instructed to take the drug 12 hours apart every day for 6 months.
干预措施: Levodopa (Drug)
结局指标
主要结局
ERG with dim flash stimuli
时间窗: Baseline, 3 and 6 months post-intervention
Full-field electroretinography (ERG) will be performed to assess rod-mediated retinal function. A skin electrode placed below the eye records the response to flash stimuli. Participants will be dark-adapted for 10 minutes to sensitive retinal rod pathways. Flash stimuli will consist of dim (1.13 Td) or bright (85 Td) flashes to reveal early dysfunction in DR.
次要结局
- Optical coherence tomography (OCT)(Baseline, 3 and 6 months post-intervention)
- Optical coherence tomography (OCT-A)(Baseline, 3 and 6 months post-intervention)
研究者
Andrew Hendrick
Associate Professor
Emory University