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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04590196
Collaborator
VitreoRetinal Surgery Foundation (Other), Illinois Society for the Prevention of Blindness (Other)
40
1
2
12
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Longvida curcumin
  • Other: placebo
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Oral Curcumin Supplementation on Choriocapillaris and Drusen Characteristics Measured by Multimodal Retinal Imaging in Dry Age-related Macular Degeneration (AMD) Patients
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Drusen volume [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 Outcome Measures

  1. Drusen size [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Illinois eye and ear infirmary Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago
  • VitreoRetinal Surgery Foundation
  • Illinois Society for the Prevention of Blindness

Investigators

  • Principal Investigator: Rajvi Mehta, md, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajvi Mehta, Resident Physician Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT04590196
Other Study ID Numbers:
  • 2019-0566
  • 096625
  • 098928
First Posted:
Oct 19, 2020
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2021