Intervention Trial in Early Age-related Macular Degeneration

Completed · Not applicable · Has a placebo group

Conditions studied: Age-related Macular Degeneration (AMD)

In brief

The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.

Key facts

Study ID

NCT01694680

Run by

Newtricious R&D BV

People needed

120

Starts

2012-10-01

Expected to finish

2016-04-01

Last updated by the study team

2016-09-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Early AMD (AREDS category 2)
• many small drusen, or
• a few intermediate-sized (63-124 micrometres in diameter) drusen, or
• macular pigmentary changes
• OR
• Intermediate AMD (AREDS category 3)
• extensive intermediate sized (63-124 micrometres in diameter) drusen, or
• at least one large (>125 micrometers in diameter) drusen or
• 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
• lutein intake of < 2 mg/day (including supplements)
• DHA intake of < 150 mg/day (including supplements)
• must be able to give written informed consent
• have normal hematologic parameters
• normal values of plasma albumin
• normal values for liver and kidney function
• no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study start)

You may not qualify if…

• 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)
• alcohol intake of >2 drinks/day or 14 drinks/week
• pancreatic disease
• dementia or Alzheimer's disease
• anemia, and bleeding disorders
• known allergy to egg or egg products
• known allergy to milk or milk products
• known allergy to cocoa or chocolate products
• known allergy to fish or fish oils
• lactose intolerance
• pregnancy or lactation
• diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview)
• medication or supplements that contain a significant level of carotenoids, including an amount of lutein of more than 0.25 mg per day within 1 month of the study start
• medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
• use of antipsychotic, anti manic, or dementia medications
• smoking or use of nicotine patches or gum (within the past 6 months)
• subjects having extremely high dietary intakes of carotenoids
• stroke, head injury with loss of consciousness or seizures
• for US and UK center: Non English speaking

Where it is running

• TUFTS University — Boston, Massachusetts, United States
• Universitäts Augenklinik - Bonn — Bonn, Germany
• Radboud University Hospital — Nijmegen, Netherlands
• Manchester Royal Eye Hospital - Manchester — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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