Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients

Effect of Oral Curcumin Supplementation on Choriocapillaris and Drusen Characteristics Measured by Multimodal Retinal Imaging in Dry Age-related Macular Degeneration (AMD) Patients

Nutrition plays an important role in preventing progression of dry age related macular degeneration (AMD), a disease of aging that leads to drusen deposits in the macula causing significant decrease in vision. Drusen contains amyloid protein which is inhibited by curcumin, a natural plant based antioxidant. Oral Longvida curcumin has been shown to accumulate in the retina of human subjects within 10 days of supplementation. This study aims to investigate the duration of oral curcumin supplementation needed to see clinical impact in reducing volume and number of drusen and decreasing choriocapillaris density loss or flow impairment in dry AMD patients. Patients will be given a 12-month course of oral Longvida curcumin and clinical impact will be measured by multimodal retinal imaging (fundus photos, OCT and OCT-A) at day 0, month 3, month 6, and month 12 of supplementation. Previous small studies have shown change in drusen size within 4 6months of curcumin supplementation, given that drusen can naturally fluctuate in size, we want to have a longer study period with a control group to better understand the effects of curcumin on drusen characteristics.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Drug: Longvida curcumin; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rajvi Mehta, MD; Phone Number: 312-970-1806; Email: mehta@uic.edu
• Study Contact Backup: Name: Jennifer Lim, MD; Phone Number: 312-996-6562; Email: jennylim@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Illinois Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age > 50 years old BCVA 20/20 to 20/400 Dry AMD with many large (>300 μm in diameter and more than 100 μm in height) soft drusenoid PEDs

Exclusion Criteria:

• presence (or history) of significant geographic atrophy or choroidal neovascularization in either eye; history of eye surgery (other than cataract extraction) within 90 days, history of BRVO/CRVO, Macular hole, pathologic myopia, uveitis, pseudovitelliform maculopathy will be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment	Drug: Longvida curcumin; longvida curcumin verdure sciences formulation
Placebo Comparator: control	Other: placebo; Composition of Placebo : 95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drusen volume	Quantify change in volume of drusen/drusenoid pigment epithelial detachments at day 0, month 3, month 6, month 12 by comparing fundus photos and OCT images obtained at these time points	baseline, 3month, 6month, 12 month timepoints

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drusen size	Quantify change in size of drusen/drusenoid pigment epithelial detachments at day 0, month 3, month 6, month 12 by comparing diameter of drusen in OCT images obtained at these time points	baseline, 3month, 6month, 12 month timepoints

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: VitreoRetinal Surgery Foundation; Illinois Society for the Prevention of Blindness
• Investigators: Principal Investigator: Yekaterina Joltikov, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 2019-0566; 096625 (Other Grant/Funding Number: Illinois Society for the Prevention of Blindness); 098928 (Other Grant/Funding Number: VitreoRetinal Surgery Foundation)

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