CT SPOTLIGHT

Back to the Egg

A Dutch company bets on high-lutein eggs to halt dry AMD.

ANDREW E. MATHIS, PhD, MEDICAL EDITOR

Since the AREDS trial found, nearly 10 years ago, that vitamin supplementation could be useful in slowing the natural history of AMD, research has intensified into nutritional links with diseases of the retina and macula.

One company conducting such research, the Netherlands-based research firm Newtricious, launched its Intervention Trial in Early Age-related Macular Degeneration (I-TEAM) study in February, which is examining the effects of a dairy drink and powder fortified with increased carotenoids and omega 3 fatty acids.

Elias Reichel, MD, professor of ophthalmology at the New England Eye Center in Boston and is an investigator in the trial, spoke with Retinal Physician about the I-TEAM study.

THE CHICKEN COMES FIRST

“The idea behind the intervention study is based on prior clinical trials in which the previously mentioned concept has been successfully tested,” Dr. Reichel says. “The composition of the product is very similar to one of the main formulations that is being tested in the current AREDS2 study. However, the egg yolk matrix results in high and highly reproducible bioavailability of the carotenoids from the dairy beverage.”

In particular, the beverage contains the carotenoid lutein, which appears in high concentrations in the retina, with the highest concentrations in the macula. There in the macula, along with zeaxanthin, lutein may protect against sunlight.

“Lutein and zeaxanthin act together as a filter for blue light and ultraviolet light,” Dr. Reichel explains. “And they also exert antioxidant effects, acting as scavengers for free radicals and singlet oxygen.”

While lutein is readily available nutritionally in green leafy vegetables and egg yolks, Newtricious is obtaining lutein from eggs that have been enriched in carotenoids and omega 3 fatty acids. “These higher levels have been achieved in hens that have been fed with special feed, which in a natural way has been enriched by selected ingredients,” Dr. Reichel says.

The product has already been tested in 100 subjects in Europe, using a design identical to that of the I-TEAM study.

STUDY DETAILS

As the agent being tested is a food-based product, the phasing typical to clinical trials does not apply. “The data resulting from the intervention study will be used to complete regulatory requirements which are planned to be submitted to the FDA,” Dr. Reichel says.

Newtricious intends to enroll a total of 120 subjects in the international clinical trial at three centers: Bonn, Germany; Manchester, United Kingdom; and Boston.

Patients with early AMD (AREDS category 2) will be randomized to receive either the lutein-enriched beverage or a placebo. Patients enrolling cannot already be supplementing their diets with lutein or with docosahexaenoic acid (DHA), an omega 3 fatty acid found in fish oils and seaweed.

The primary outcome measurement for the trial will be visual function at 12 months. As a secondary measurement, blood levels of lutein, zeaxanthin, and carotenoids will be monitored.

For more information on the I-TEAM study, including the inclusion and exclusion criteria, please see page 68 of this issue, go online to http://clinicaltrials.gov/ct2/show/NCT01694680. Newtricious also has a Web site (in English and Dutch) www.newtricious.nl. RP