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

NCT05062486 | Completed Phase 2 FDA Drug

• 1 other identifier: ZK-01-2021
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Age-related Macular Degeneration

Keywords

Curcumin; Resveratrol; Quercetin; Macular Degeneration, Age-Related; Age-Related Maculopathy; Adult Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• Change in Drusen Volume from Baseline

  Macular drusen volume measured in µm3.

  24 months

• Geographic Atrophy (GA) Growth Rate

  The annual growth rate of GA or nascent GA area measured in mm2.

  24 months

• Progression to Moderate Vision Loss

  Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.

  24 months

• Adverse Events

  Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.

  24 months

Secondary Outcomes (1)

• Progression to Advanced AMD

  24 months

Study Arms (2)

Resveratrol, Quercetin, Curcumin (RQC)

EXPERIMENTAL

Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months

Drug: Resveratrol, Quercetin, Curcumin (RQC)

Curcumin

ACTIVE COMPARATOR

Curcumin (1000mg BID); 24 months

Drug: Curcumin

Interventions

Resveratrol, Quercetin, Curcumin (RQC) DRUG

100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID

Resveratrol, Quercetin, Curcumin (RQC)

Curcumin DRUG

1000 mg curcumin BID

Curcumin

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul A Knepper, MD PhD: lead

Study Sites (1)

Zaparackas M.D. & Knepper M.D. Ph.D., Ltd

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Macular Degeneration

Interventions

Resveratrol; Quercetin; Curcumin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Catechols

Study Officials

• Paul A Knepper, MD, PhD

  Zaparackas Knepper, Ltd

  PRINCIPAL INVESTIGATOR

• Zibute Zaparackas, MD

  Zaparackas Knepper, Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 30, 2021
• Study Start: October 4, 2021
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)