An Open-Label, Randomized, Double Arm, Phase 2 Study to Evaluate the Safety and Efficacy of C and RQC for Preventing Progression in Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Progression to Moderate Vision Loss
研究概览
简要总结
To evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) over 2 years in patients with age-related macular degeneration (AMD).
详细描述
The objective of the study is to institute an open-label, randomized, double arm, phase 2 study to evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) versus curcumin alone (C) in AMD. The primary outcomes are change in drusen volume, geographic atrophy growth rate, and progression to moderate vision loss. Progression to advanced AMD will serve as a secondary outcome measure. Participants are classified by pre-AMD severity at baseline and randomized into either the C (n=50) or RQC (n=150) arm. Curcumin is taken orally at a dose of 1000 mg twice per day. RQC is taken orally at a dose of 100 mg resveratrol, 120 mg quercetin, and 1000 mg curcumin twice per day. The study will be conducted over 2 years with follow-up visits at least every 6 months.
Safety is evaluated using adverse event reporting, vital sign/physical examinations, and blood testing. Efficacy is evaluated using a series of OCT-based retinal photography and image processing techniques to measure drusen volume, GA area, and the presence of advanced disease (GA or wet AMD). Progression to moderate vision loss is defined as a loss of 15 letters on the Early Treatment for Diabetic Retinopathy Study (ETDRS) charts. The status of 15 single nucleotide polymorphisms reported to be associated with AMD are analyzed and incorporated as covariates into multivariate models of primary and secondary outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race or ethnicity.
- •Aged 50-90 years at time of study entry.
- •Ability to speak, read, and understand English.
- •Ability to take oral medication and be willing to adhere to the study regimen.
- •Capable of providing informed consent/provision of signed and dated informed consent.
- •Stated willingness to comply with all procedures and availability for the duration of the study.
- •Diagnosis of dry AMD (AREDS categories Early, drusen 63-124 µm in width; Intermediate, drusen ≥125 µm in width; or Advanced, macular geographic atrophy) as documented by OCT and/or color retinal photography.
排除标准
- •Participation in another clinical study with an investigational product during the last 90 days.
- •The presence of wet AMD.
- •The presence of ocular disease or condition that may confound evaluation of the retina or could require medical or surgical intervention.
- •Previous retinal or other ocular surgical procedures (other than cataract extraction) that may have complicated assessment of the progression of AMD.
- •A serious or complex systemic medical disease or condition with a poor five-year survival prognosis or that would make adherence or follow-up difficult or unlikely.
- •Diagnosis of Alzheimer's disease or dementia, diagnosis of a serious gastrointestinal or stomach condition, or positive for HIV, hepatitis B surface antigen, or hepatitis C antibodies.
- •History of inherited bleeding disorder.
- •Use of any anticoagulant medication within 5 days before the first dose of investigative product is scheduled or required for subsequent medical treatment in the course of the study.
- •Clinically significant abnormal physical examination/vital signs or laboratory and coagulation blood tests as deemed appropriate by the investigator.
- •History of or a reason to believe participant has a history of drug or alcohol abuse within the past 5 years.
- •History of known allergy to any component of the investigational product.
- •Preplanned surgery or procedures that would interfere with the conduct of the study.
- •Currently incarcerated prisoners.
- •Currently pregnant or lactating.
研究组 & 干预措施
Curcumin
Curcumin (1000mg BID); 24 months
干预措施: Curcumin (Drug)
Resveratrol, Quercetin, Curcumin (RQC)
Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months
干预措施: Resveratrol, Quercetin, Curcumin (RQC) (Drug)
结局指标
主要结局
Progression to Moderate Vision Loss
时间窗: 24 months
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Change in Drusen Volume from Baseline
时间窗: 24 months
Macular drusen volume measured in µm3.
Geographic Atrophy (GA) Growth Rate
时间窗: 24 months
The annual growth rate of GA or nascent GA area measured in mm2.
Adverse Events
时间窗: 24 months
Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.
次要结局
- Progression to Advanced AMD(24 months)
研究者
Paul A Knepper, MD PhD
Sponsor-Investigator
Zaparackas and Knepper LTD