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

September 20, 2021 updated by: Paul A Knepper, MD PhD

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Zaparackas M.D. & Knepper M.D. Ph.D., Ltd
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul A Knepper, MD, PhD
        • Principal Investigator:
          • Zibute Zaparackas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female of any race or ethnicity.
  2. Aged 50-90 years at time of study entry.
  3. Ability to speak, read, and understand English.
  4. Ability to take oral medication and be willing to adhere to the study regimen.
  5. Capable of providing informed consent/provision of signed and dated informed consent.
  6. Stated willingness to comply with all procedures and availability for the duration of the study.
  7. 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.

Exclusion Criteria:

  1. Participation in another clinical study with an investigational product during the last 90 days.
  2. The presence of wet AMD.
  3. The presence of ocular disease or condition that may confound evaluation of the retina or could require medical or surgical intervention.
  4. Previous retinal or other ocular surgical procedures (other than cataract extraction) that may have complicated assessment of the progression of AMD.
  5. 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.
  6. 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.
  7. History of inherited bleeding disorder.
  8. 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.
  9. Clinically significant abnormal physical examination/vital signs or laboratory and coagulation blood tests as deemed appropriate by the investigator.
  10. History of or a reason to believe participant has a history of drug or alcohol abuse within the past 5 years.
  11. History of known allergy to any component of the investigational product.
  12. Preplanned surgery or procedures that would interfere with the conduct of the study.
  13. Currently incarcerated prisoners.
  14. Currently pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol, Quercetin, Curcumin (RQC)
Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months
Drug: Resveratrol, Quercetin, Curcumin (RQC)
100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID
Active Comparator: Curcumin
Curcumin (1000mg BID); 24 months
Drug: Curcumin
1000 mg curcumin BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Drusen Volume from Baseline
Time Frame: 24 months
Macular drusen volume measured in µm3.
24 months
Geographic Atrophy (GA) Growth Rate
Time Frame: 24 months
The annual growth rate of GA or nascent GA area measured in mm2.
24 months
Progression to Moderate Vision Loss
Time Frame: 24 months
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
24 months
Adverse Events
Time Frame: 24 months
Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to Advanced AMD
Time Frame: 24 months
Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul A Knepper, MD PhD

Investigators

  • Principal Investigator: Paul A Knepper, MD, PhD, Zaparackas Knepper, Ltd
  • Principal Investigator: Zibute Zaparackas, MD, Zaparackas Knepper, Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZK-01-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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