Intervention study to assess the effect of daily consumption of a lutein-enriched-egg beverage on maintenance of visual function in subjects with early signs of Age-related Macular Degeneratio

Phase 3

Completed

• Conditions: Age-related Macular Degeneration; AMD; Macular Disease; 10047060

• Registration Number: NL-OMON41009
• Lead Sponsor: ewtricious R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Early AMD (AREDS category 2)
o many small drusen, or
o a few intermediate-sized (63-124 micrometres in diameter) drusen, or
macular pigmentary changes
OR
- Intermediate AMD (AREDS category 3)
o extensive intermediate sized (63-124 micrometres in diameter) drusen, or
o at least one large (>125 micrometres in diameter) drusen or
o geographic atrophy not involving the foveal centre
- men and women age >50 years
- BMI 18-35 kg/m2
- Vision > 20/40 for Snellen visual acuity

Exclusion Criteria

- ocular media opacity (severe cataract)
- history of active small bowel disease or resection
- atrophic gastritis
- history of hyperlipidemia or screening values as follows (LDL > 5.33mmol/L or 205mg/dL;
triglycerides > 4.52mmol/L or 400 mg/dL)
- hypertension (>150/90 mm Hg)
- diabetes mellitus (if also accompanied by signs of diabetic retinopathy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the visual function by Best Corrected Visual Acuity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the visual function by Contrast Sensitivity.<br /><br>To assess morphological changes of the retina by fundus photography.<br /><br>To assess Visual performance and experience by questionnaire.<br /><br>To assess Fundus Auto fluorescence.<br /><br>To obtain information about both macular pigment density and distribution from<br /><br>double wavelength Fundus Auto fluorescence is performed at Bonn University.<br /><br>To measure Macular Pigment Optical Density (MPOD), Plasma lutein and zeaxanthin<br /><br>levels, and to review a blood safety panel.<br /><br>To assess dark adaptation at one centre (Manchester University)<br /><br>To assess Cognitive function by psychometric testing in a subgroup (n=40) in<br /><br>one centre (Tufts University, Boston, MA, USA).</p><br>