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

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ClinicalTrials.gov Identifier: NCT00879671
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Dietary Supplement: lutamax (leutein) Dietary Supplement: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Study Start Date : November 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Lutamax
Dietary Supplement: lutamax (leutein)
leutein 20 mg for 3 months, then lutein 10 mg
Placebo Comparator: 2
Placebo
Dietary Supplement: placebo
Placebo capsules identical in taste and appearance



Primary Outcome Measures :
  1. Macular pigment optical density (MPOD) as measured with optical reflectometry [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879671


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ursula Schmidt-Erfurth, Prof. Dr. Department of Opthalmology, Medical University of Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv.-Doz., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00879671     History of Changes
Other Study ID Numbers: OPHT-100205
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
lutein
nonexudative AMD
MPOD
Supplementary Concepts

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases