Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients
Primary Purpose
Age Related Macular Degeneration
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Longvida curcumin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration
Eligibility Criteria
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.
Sites / Locations
- Illinois eye and ear infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment
control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04590196
First Posted
October 4, 2020
Last Updated
June 20, 2023
Sponsor
University of Illinois at Chicago
Collaborators
VitreoRetinal Surgery Foundation, Illinois Society for the Prevention of Blindness
1. Study Identification
Unique Protocol Identification Number
NCT04590196
Brief Title
Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
VitreoRetinal Surgery Foundation, Illinois Society for the Prevention of Blindness
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Longvida curcumin
Intervention Description
longvida curcumin verdure sciences formulation
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Composition of Placebo :
95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide
Primary Outcome Measure Information:
Title
Drusen volume
Description
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
Time Frame
baseline, 3month, 6month, 12 month timepoints
Secondary Outcome Measure Information:
Title
Drusen size
Description
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
Time Frame
baseline, 3month, 6month, 12 month timepoints
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yekaterina Joltikov, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois eye and ear infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients
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