Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Drusen volume analysis
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of low doses of antiplatelet medications (aspirin 81 mg/day or clopidogrel 75 mg/day) with or without a combination of antioxidants (N-acetylcysteine 600 mg/day) in a dry AMD patient with large drusen.
Participants will divided in to three groups.
- Participants who were already taking low dose antiplatelet medications.
- Participants who take the antiplatelet drug mentioned above in addition to the antioxidant prescribed by the investigator
- Participants does not use any medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Dry AMD with at least 1 large drusen. According to the AREDS study, large drusen have a size of more than 125 micron.
- •Patients can evaluate SD-OCT (Spectral domain optical coherence tomography), OCT angiography, and best-corrected visual acuity.
- •Age range: 50-85 years
- •Patients who have previously used antiplatelet drugs.
排除标准
- •Patient with advanced AMD, such as geographic atrophy, neovascular complications (choroidal neovascularization)
- •Patient with additional retinal diseases that affect visual acuity, e.g., retinal detachment, diabetic macular edema.
- •Patient with a history of intravitreal anti-VEGF injection or macular laser.
- •Patient using SSRIs, SNRIs, azole, NSAIDs, dual antiplatelet, anticoagulant medications.
研究组 & 干预措施
Antiplatelet drug
In this study, antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day.
干预措施: Aspirin 81Mg Ec Tab (Drug)
Antiplatelet drug
In this study, antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day.
干预措施: Clopidogrel (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
干预措施: Aspirin 81Mg Ec Tab (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
干预措施: Clopidogrel (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Drusen volume analysis
时间窗: 1 year
To assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan
次要结局
- Side effects of medications intake(1 year)
- Best-corrected visual acuity change(1 year)
- Rate of disease progression(1 year)
研究者
Yolradee Winuntamalakul
Principal Investigator
Navamindradhiraj University