Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration

Study Overview
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Brief Summary
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The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina. Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.

Official Title
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Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: lutamax (leutein)
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001) Age between 50 and 90 years Clear non-lenticular ocular media Visual acuity > 0.4 Exclusion Criteria: Primary retinal pigment epithelium atrophy > 125 µm Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy Participation in a clinical trial in the 3 weeks preceding the study Previous treatment with lutein within 3 month of study initiation History of hypersensitivity to the trial drug or to drugs with a similar chemical structure History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs Ocular surgery within the last 6 months Treatment with photosensitizing drugs

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Lutamax | Dietary Supplement: lutamax (leutein)<br>* leutein 20 mg for 3 months, then lutein 10 mg<br>|
| Placebo Comparator: 2<br>Placebo | Dietary Supplement: placebo<br>* Placebo capsules identical in taste and appearance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular pigment optical density (MPOD) as measured with optical reflectometry |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity using ETDRS charts |  | 15 minutes | 
| Central visual field defects assessed with scanning laser scotometry |  | 30 minutes | 
| Changes in fundus appearance as documented with fundus photos |  | 5 minutes | 
| Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations |  | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lutein, nonexudative AMD, MPOD, Supplementary Concepts