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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID
1000 mg curcumin BID
Zaparackas M.D. & Knepper M.D. Ph.D., Ltd
Chicago, Illinois, United States
Change in Drusen Volume from Baseline
Macular drusen volume measured in µm3.
Time frame: 24 months
Geographic Atrophy (GA) Growth Rate
The annual growth rate of GA or nascent GA area measured in mm2.
Time frame: 24 months
Progression to Moderate Vision Loss
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Time frame: 24 months
Adverse Events
Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.
Time frame: 24 months
Progression to Advanced AMD
Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules.
Time frame: 24 months
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