NCT00763659

Brief Summary

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

September 30, 2008

Last Update Submit

July 19, 2012

Conditions

Age Related Maculopathy

Outcome Measures

Primary Outcomes (1)

  • Optical density of macular pigment

    12 months

Study Arms (3)

1

ACTIVE COMPARATOR

20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

2

ACTIVE COMPARATOR

10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

3

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Lutein/ Zeaxanthin + Omega-3-FADIETARY_SUPPLEMENT

20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year

1
PlaceboDIETARY_SUPPLEMENT

0 mg Lutein, Zeaxanthin, Omega-3-FA

3

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All non- exudative forms of age related maculopathy

You may not qualify if:

  • Exudative age related maculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital

Jena, 07743, Germany

Location

Related Publications (3)

  • 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

  • Dawczynski J, Jentsch S, Schweitzer D, Hammer M, Lang GE, Strobel J. Long term effects of lutein, zeaxanthin and omega-3-LCPUFAs supplementation on optical density of macular pigment in AMD patients: the LUTEGA study. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2711-23. doi: 10.1007/s00417-013-2376-6. Epub 2013 May 22.

    PMID: 23695657DERIVED

  • Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.

    PMID: 23519529DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

LuteinZeaxanthins

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Jürgen Strobel, MD

    University Hospital, Jena

    STUDY DIRECTOR

  • Jens Dawczynski, MD

    University Hospital, Jena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. jens Dawczynski

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

DE(1)