NL-OMON41009CompletedPhase 3
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 Degeneration - I-TEAM (Intervention Trial in Early Age-related Macular degeneration)
ewtricious R&D0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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)
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