Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)

Study Overview
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Brief Summary
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The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage groups are crossed after LUTEGA 1.

Detailed Description
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The LUTEGA 2 is a cross-over- study and the continue of LUTEGA 1. After one year of supplementation in randomized, placebo- controlled, double blind study (LUTEGA 1), the treatment arms are unblind to cross over the different dosage groups. The measurement of optical density of macular pigment (MPOD) uses the 1- wavelength reflection method recording reflection images at 480 nm by a fundus camera. The patients are followed up over two years in eight more visits (every three months) In addition to the MPOD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample (every six months).

Official Title
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Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients for Two More Years (LUTEGA 2)

Conditions
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Age Related Maculopathy

Intervention / Treatment
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* Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All non- exudative forms of age related maculopathy Exclusion Criteria: Exudative age related maculopathy decrease opacity of ocular media

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2x - D1x<br>Cross Over from double dosage to single dosage: daily supplementation with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FAabout two years after one year with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA | Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids<br>* capsule with Lutein, Zeaxanthin, Omega-3-FA for two years<br>|
| Active Comparator: D1x - D2x<br>Cross Over from double dosage to single dosage: daily supplementation with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA | Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids<br>* capsule with Lutein, Zeaxanthin, Omega-3-FA for two years<br>|
| Active Comparator: D1x - D1x<br>single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing) | Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids<br>* capsule with Lutein, Zeaxanthin, Omega-3-FA for two years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical density of macular pigment |  | 24 months |