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

Primary Purpose

Age-Related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

lutamax (leutein)

placebo

About this trial

This is an interventional prevention trial for Age-Related Macular Degeneration focused on measuring lutein, nonexudative AMD, MPOD, Supplementary Concepts

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Lutamax

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual acuity using ETDRS charts

Central visual field defects assessed with scanning laser scotometry

Changes in fundus appearance as documented with fundus photos

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

Full Information

NCT ID

NCT00879671

First Posted

April 9, 2009

Last Updated

November 13, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00879671

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration

Keywords

lutein, nonexudative AMD, MPOD, Supplementary Concepts

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Lutamax

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

lutamax (leutein)

Intervention Description

leutein 20 mg for 3 months, then lutein 10 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

Placebo capsules identical in taste and appearance

Primary Outcome Measure Information:

Title

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

Time Frame

5 minutes

Secondary Outcome Measure Information:

Title

Visual acuity using ETDRS charts

Time Frame

15 minutes

Title

Central visual field defects assessed with scanning laser scotometry

Time Frame

30 minutes

Title

Changes in fundus appearance as documented with fundus photos

Time Frame

5 minutes

Title

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

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ursula Schmidt-Erfurth, Prof. Dr.

Organizational Affiliation

Department of Opthalmology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

21873668

Citation

Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhofer G, Schmidt-Erfurth U, Schmetterer L. Effects of lutein supplementation on macular pigment optical density and visual acuity in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522.

Results Reference

derived

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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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