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

Study Overview
=================
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.

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

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Longvida curcumin
* Other: placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Drug: Longvida curcumin<br>* longvida curcumin verdure sciences formulation<br>|
| Placebo Comparator: control<br> | Other: placebo<br>* Composition of Placebo : 95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 3month, 6month, 12 month timepoints |