A Pilot Phase I/II Study for the Evaluation of Dextromethorphan as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema (MiDME2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline
研究概览
简要总结
Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema.
Objectives: To see if dextromethorphan can help treat diabetic macular edema.
Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye.
Design:
- This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours.
- Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing.
- Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken.
- Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests.
- Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
详细描述
Objective:
Diabetic retinopathy (DR) is one of the leading causes of blindness in the United States. A frequent manifestation of DR is diabetic macular edema (DME) for which the only proven treatment is laser photocoagulation. In the retina, microglia are capable of migrating through the retina to sites of inflammation to associate closely with neurons and the vasculature, and are key cellular players in the mediation of processes of chronic inflammation implicated in DME. For these reasons, microglia represent a promising cellular target for forms of therapy that limit the deleterious inflammatory changes found in DR. The objective of this study is to investigate the safety and efficacy of dextromethorphan as a microglia inhibitor in participants with DME.
Study Population:
Eligibility criteria include presence of diabetic retinopathy with retinal thickening due to diabetic macular edema within 3000 μm of the center of the macula as measured by optical coherence tomography (OCT), and visual acuity better than 20/200 in the study eye.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dextromethorphan hydrobromide
干预措施: Dextromethorphan hydrobromide (Drug)
结局指标
主要结局
Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline
时间窗: Baseline and 6 months
Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."
次要结局
- Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline(Baseline and 12 Months)
- Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline(Baseline and 18 Months)
- Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline(Baseline and 24 Months)
- Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline(Baseline and 6 Months)
- Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline(Baseline and 12 Months)
- Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline(Baseline and 18 Months)
- Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline(Baseline and 24 Months)
- Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline(Baseline and 6 Months)
- Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline(Baseline and 12 Months)
- Changes in Mean Macular Sensitivity in the Study Eye at 6 Months Compared to Baseline(Baseline and 6 Months)
- Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline(Baseline and 18 Months)
- Changes in Mean Macular Sensitivity in the Study Eye at 12 Months Compared to Baseline(Baseline and 12 Months)
- Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline(Baseline and 24 Months)
- Changes in Mean Macular Sensitivity in the Study Eye at 18 Months Compared to Baseline(Baseline and 18 Months)
- Changes in Mean Macular Sensitivity in the Study Eye at 24 Months Compared to Baseline(Baseline and 24 Months)
- Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events(Duration of the study, up to 24 months)