Carotenoids and Co-Antioxidants in Age-Related Maculopathy: Design and Methods

Abstract

Age-related macular degeneration (AMD), is the leading cause of blind registration in the Western World among individuals 65 years or older. Early AMD, a clinical state without overt functional loss, is said to be present clinically when yellowish deposits known as drusen and/or alterations of fundus pigmentation are seen in the macular retina. Although the etiopathogenesis of AMD remains uncertain, there is a growing body of evidence in support of the view that cumulative oxidative damage plays a causal role. Appropriate dietary antioxidant supplementation is likely to be beneficial in maintaining visual function in patients with AMD, and preventing or delaying the progression of early AMD to late AMD. The Carotenoids in Age-Related Maculopathy (CARMA) Study is a randomized and double-masked clinical trial of antioxidant supplementation versus placebo in 433 participants with either early AMD features of sufficient severity in at least one eye or any level of AMD in one eye with late AMD (neovascular AMD or central geographic atrophy) in the fellow eye. The aim of the CARMA Study is to investigate whether lutein and zeaxanthin, in combination with co-antioxidants (vitamin C, E, and zinc), has a beneficial effect on visual function and/or prevention of progression from early to late stages of disease. The primary outcome is improved or preserved distance visual acuity at 12 months. Secondary outcomes include improved or preserved interferometric acuity, contrast sensitivity, shape discrimination ability, and change in AMD severity as monitored by fundus photography. This article outlines the CARMA Study design and methodology, including its rationale.

Supplementation With Three Different Macular Carotenoid Formulations in Patients With Early Age-Related Macular Degeneration

“…For the purposes of discussion, it is reasonable to compare our findings with the placebo group in the recently published Carotenoids in Age-Related MAculopathy study, which was a randomized, double-blind, placebo-controlled clinical trial of L (12 mg) and Z (0.6 mg) supplementation with co-antioxidants versus placebo in patients with early AMD. 61 The study population of the Carotenoids in Age-Related MAculopathy study is comparable with that of our study, in inclusion and exclusion criteria, methodology of AMD grading, and demographic and geographic considerations. However, in the Carotenoids in AgeRelated MAculopathy study, at 12 months, 47.4% of eyes in the placebo arm (108 of 228 eyes) exhibited an increase of least one grade (progression) along the AMD severity scale (data on file).…”

Retinal light toxicity

“…149,150 While the role of macular pigment optical density remains of limited clinical use at this time, studies such as the Carotenoids and co-antioxidants in age-related maculopathy are investigating the use of macular pigment optical density measurement in relating dietary carotenoid supplementation on the progression of ARMD. 151 Sunlight exposure and age-related macular degeneration…”

Role of Dietary Supplementation in Preventing Progression of Age-Related Macular Degeneration

“…лируемое двойное слепое исследование, проведенное у 433 лиц 50 лет или старше, показало, что использова-ние лютеина (6 mg), зеаксантина (0.3 mg), витаминов С (75 mg) и Е (7.5 mg), цинка (10 mg) и меди (0.2 mg) способ-ствовало сохранению зрительных функций и замедляло переход заболевания в продвинутую фазу ВМД [36].…”