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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879671
• Other study ID #: OPHT-100205
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: November 13, 2014
• Start date: November 2006
• Est. completion date: May 2011

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• lutamax (leutein)
leutein 20 mg for 3 months, then lutein 10 mg
• placebo
Placebo capsules identical in taste and appearance

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular pigment optical density (MPOD) as measured with optical reflectometry		5 minutes	No
Secondary	Visual acuity using ETDRS charts		15 minutes	No
Secondary	Central visual field defects assessed with scanning laser scotometry		30 minutes	No
Secondary	Changes in fundus appearance as documented with fundus photos		5 minutes	No
Secondary	Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations		5 minutes	No