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Completed

NCT Number: NCT00879671

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lutamax (leutein)

Dietary Supplement

leutein 20 mg for 3 months, then lutein 10 mg

Placebo

Dietary Supplement

Placebo capsules identical in taste and appearance

Primary outcomes

  1. Macular pigment optical density (MPOD) as measured with optical reflectometry

    Time frame: 5 minutes

Secondary outcomes

  1. Visual acuity using ETDRS charts

    Time frame: 15 minutes

  2. Central visual field defects assessed with scanning laser scotometry

    Time frame: 30 minutes

  3. Changes in fundus appearance as documented with fundus photos

    Time frame: 5 minutes

  4. Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2009
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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