Extension of Protocol 002, Carbidopa-levodopa in Neovascular Extension of Protocol 002, Carbidopa-levodopa in Neovascular AMD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing
研究概览
简要总结
This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.
详细描述
This extension will employ the same medications, measurements, guidelines for anti-VEGF injections and safeguards as in protocol 0002. In combination with protocol 0002, it will provide a total of 12 months of therapy with carbidopa-levodopa.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of Protocol
- •A diagnosis of AMd with choroidal neovascularization (CNV) in 1 eye.
- •Normal or Dry AMD of any grade in the second eye.
- •Age 50-85 years.
- •Willingness to maintain AREDS vitamin Supplements throughout the study, or remain off of these supplements for the duration of the study, if not taking them prior to the study.
- •Informed consent at visit 1, which is also Visit 5 of study
- •Exclusion criteria:
- •Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study;
- •Concurrent use of monoamine oxidase (MAO) inhibitors;
- •Any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery;
- •BCVA worse than 20/60 in the better eye;
- •Wet AMD in the second eye;
- •Neurologic conditions which can impair vision;
- •Parkinson's Disease;
- •Significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position;
- •Significant ECG abnormalities, as judged by the Investigator;
- •Estimated glomerular filtration rate (eGFR) <20 ml/min;
- •Liver enzymes >3 X the upper limit of normal;
- •HbA1C >9.0;
- •Any other significant lab abnormalities, as judged by the Investigator.
- •Women of childbearing potential;
- •Known retinal hemorrhage;
- •Subjects who are not fluent in English.
排除标准
- 未提供
研究组 & 干预措施
Carbidopa/levodopa high dose
carbidopa-levodopa 25-100 mg 2 tablets TID
干预措施: carbidopa-levodopa 25-100 mg (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing
时间窗: From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.
This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity.
次要结局
- Number of Adverse Events Experienced(Monthly for 9 months)
- Change in Central Retinal (Macular) Thickness(From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, a maximum of 9 months.)
- Percent Change in Retinal Fluid From Baseline(From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, (visit 10), a maximum of 9 months.)