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OpenTrials
Completed

NCT Number: NCT04590196

Effect of Oral Curcumin Supplementation 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Illinois eye and ear infirmary

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Longvida curcumin

Drug

longvida curcumin verdure sciences formulation

Placebo

Other

Composition of Placebo :

95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide

Primary outcomes

  1. Drusen volume

    Time frame: baseline, 3month, 6month, 12 month timepoints

    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

Secondary outcomes

  1. Drusen size

    Time frame: baseline, 3month, 6month, 12 month timepoints

    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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Illinois Society for the Prevention of Blindness
  • VitreoRetinal Surgery Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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