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

Primary Purpose

Age-related Macular Degeneration

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Resveratrol, Quercetin, Curcumin (RQC)

Curcumin

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Curcumin, Resveratrol, Quercetin, Macular Degeneration, Age-Related, Age-Related Maculopathy, Adult Macular Degeneration

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resveratrol, Quercetin, Curcumin (RQC)

Curcumin

Arm Description

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

Curcumin (1000mg BID); 24 months

Outcomes

Primary Outcome Measures

Change in Drusen Volume from Baseline

Macular drusen volume measured in µm3.

Geographic Atrophy (GA) Growth Rate

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

Progression to Moderate Vision Loss

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

Adverse Events

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05062486

First Posted

September 8, 2021

Last Updated

September 20, 2021

Sponsor

Paul A Knepper, MD PhD

1. Study Identification

Unique Protocol Identification Number

NCT05062486

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul A Knepper, MD PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resveratrol, Quercetin, Curcumin (RQC)

Arm Type

Experimental

Arm Description

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

Arm Title

Curcumin

Arm Type

Active Comparator

Arm Description

Curcumin (1000mg BID); 24 months

Intervention Type

Drug

Intervention Name(s)

Resveratrol, Quercetin, Curcumin (RQC)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Curcumin

Intervention Description

1000 mg curcumin BID

Primary Outcome Measure Information:

Title

Change in Drusen Volume from Baseline

Description

Macular drusen volume measured in µm3.

Time Frame

24 months

Title

Geographic Atrophy (GA) Growth Rate

Description

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

Time Frame

24 months

Title

Progression to Moderate Vision Loss

Description

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

Time Frame

24 months

Title

Adverse Events

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Progression to Advanced AMD

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephanie Aman, BS

Phone

3123371285

knezap@sbcglobal.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul A Knepper, MD, PhD

Organizational Affiliation

Zaparackas Knepper, Ltd

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zibute Zaparackas, MD

Organizational Affiliation

Zaparackas Knepper, Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Aman

Phone

312-337-1285

knezap@sbcglobal.net

First Name & Middle Initial & Last Name & Degree

Zibute Zaparackas, MD

Phone

3123371285

knezap@sbcglobal.net

First Name & Middle Initial & Last Name & Degree

Paul A Knepper, MD, PhD

First Name & Middle Initial & Last Name & Degree

Zibute Zaparackas, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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