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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul A Knepper, MD PhD
• Treatments: Curcumin; Quercetin; Resveratrol

Criteria

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.