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

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University of Illinois

Status and phase

Completed
Early Phase 1

Conditions

Age Related Macular Degeneration

Treatments

Drug: Longvida curcumin
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04590196
098928 (Other Grant/Funding Number)
2019-0566
096625 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups, including a placebo group

treatment
Experimental group
Treatment:
Drug: Longvida curcumin
control
Placebo Comparator group
Treatment:
Other: placebo

Trial contacts and locations

1

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Central trial contact

Rajvi Mehta, MD; Jennifer Lim, MD

Data sourced from clinicaltrials.gov

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