NCT00879671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

4.4 years

First QC Date

April 9, 2009

Last Update Submit

November 13, 2014

Conditions

Age-Related Macular Degeneration

Keywords

luteinnonexudative AMDMPODSupplementary Concepts

Outcome Measures

Primary Outcomes (1)

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

    5 minutes

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Lutamax

Dietary Supplement: lutamax (leutein)

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: placebo

Interventions

lutamax (leutein)DIETARY_SUPPLEMENT

leutein 20 mg for 3 months, then lutein 10 mg

1
placeboDIETARY_SUPPLEMENT

Placebo capsules identical in taste and appearance

2

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Related Publications (2)

  • Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

    PMID: 37702300DERIVED

  • 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.

    PMID: 21873668DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ursula Schmidt-Erfurth, Prof. Dr.

    Department of Opthalmology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz.

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Study Start

November 1, 2006

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

AU(1)