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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590196
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : June 2, 2021
Sponsor:
Collaborators:
VitreoRetinal Surgery Foundation
Illinois Society for the Prevention of Blindness
Information provided by (Responsible Party):
Rajvi Mehta, University of Illinois at Chicago

Study Description
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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
Age Related Macular Degeneration Drug: Longvida curcumin Other: placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590196


Contacts
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Contact: Rajvi Mehta, MD 312-970-1806 mehta@uic.edu
Contact: Jennifer Lim, MD 312-996-6562 jennylim@uic.edu

Locations
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United States, Illinois
Illinois eye and ear infirmary Recruiting
Chicago, Illinois, United States, 60612
Contact: Rajvi Mehta, MD    312-970-1806    mehta30@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
VitreoRetinal Surgery Foundation
Illinois Society for the Prevention of Blindness
Investigators
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Principal Investigator: Rajvi Mehta, md University of Illinois at Chicago
More Information
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Responsible Party: Rajvi Mehta, Resident Physician Ophthalmology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04590196    
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 )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action