A Study to Evaluate the Safety and Efficacy of RQC for AMD

Age-related Macular Degeneration Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

• NCT number: NCT05062486
• Study type: Interventional
• Source: Zaparackas and Knepper LTD
• Contact: Stephanie Aman, BS
• Phone: 3123371285
• Email: knezap@sbcglobal.net
• Status: Recruiting
• Phase: Phase 2
• Start date: July 22, 2021
• Completion date: February 2023