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

NCT04590196 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: 2019-0566096625098928
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Drusen size

  baseline, 3month, 6month, 12 month timepoints

Study Arms (2)

treatment

EXPERIMENTAL

Drug: Longvida curcumin

control

PLACEBO COMPARATOR

Other: placebo

Interventions

Longvida curcumin DRUG

longvida curcumin verdure sciences formulation

treatment

placebo OTHER

Composition of Placebo : 95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide

control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Illinois eye and ear infirmary

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Yekaterina Joltikov, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Ophthalmology

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)