gms | German Medical Science

Severe visual loss in AMD results either from choroidal neovascularization, pigment epithelial detachment or from geographic atrophy (GA) of the retinal pigment epithelium (RPE). Currently there is no treatment availabe for patients with GA. In the Age-Related Eye Disease Study (AREDS) a prophylactic effect of high doses of antioxidants (vitamins C and E, β-carotin) and zinc with regard to the progression from early to late AMD stages was reported. The objective of this randomized, controlled, double-masked, multi-center trial is to determine the effect of lutein, vitamins C and E, and zinc given as daily oral medication for 3 years on the progression of GA in AMD (GAM-Study).

In the Fundus Autofluorescence in age-related Macular Degeneration (FAM)-Study we investigated the natural history of GA using cSLO fundus autofluorescence (FAF) imaging. Rates of spread of GA over time as well as prognostic factors including FAF characteristics were determined. Based on these data sample size calculations were carried out for the GAM-Study. In a randomised parallel group trial which attempts to show a reduction of the speed of GA growth of 30% on a significance level of 5% (α = 0.05) and with a power of 80% (β = 0.2), 166 patients per group need to be recruited. Assuming a 20% drop out rate, a total sample size of 465 patients is required. The formula of drugs will consist of 7.5 mg Lutein, 500 mg vitamin C, 400 IU vitamin E and 80 mg zinc. Regular examinations in 6 months intervals will include FAF imaging, fundus photography, visual acuity testing (ETDRS) and buccal mucosa analyses for concentrations of lutein. The primary efficacy endoint is a comparison of the enlargement of atrophy using digital analysis of cSLO FAF images. Secondary efficacy endpoint includes lost of <15 letters (ETDRS) at 104 weeks.