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

Early Phase 1

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Other: placebo; Drug: Longvida curcumin

• Registration Number: NCT04590196
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-11
• Study First Posted: 2020-10-19
• Study Start: 2020-11-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	placebo	-
treatment	Longvida curcumin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Illinois eye and ear infirmary; 🇺🇸 Chicago, Illinois, United States