The Radiation of Age-Related Macular Degeneration (ROARMD) study

Purpose. The ROARMD study is a prospective, randomized trial designed to determine whether low dose, external beam irradiation is effective in the treatment of choroidal neovascularization (CNV) complicating age-related macular degeneration (ARMD). Methods. Thirty one patients with active CNV secondary to ARMD have been enrolled. Patients with classic, well-defined juxta or extrafoveal lesions were randomized to laser alone versus laser plus adjuvant radiation. Patients with subfoveal or occult lesions were randomized to observation versus radiation. Eight patients with recurrent CNV were non-randomized and treated. Fourteen Gy are administered in 7 fractions via a custom designed collimator. Small field, CT-guided treatment planning is used to precisely administer macular radiation while limiting lens involvement. Fluorescein angiography, visual acuity, contrast sensitivity and visual field were analyzed. Results. At 3 months follow-up, 50% of non-randomized treated patients with recurrent CNV demonstrate stable (within 2 lines of baseline) visual acuity, while 50% of this group demonstrate a loss of 3 lines. Analysis of contrast sensitivity and visual acuity for randomized groups at 3 months follow-up demonstrate no statistically significant harmful or beneficial effects. No adverse effects of radiation were seen. Conclusions. Further follow-up and enrollment in a prospective, randomized manner is necessary to determine the effect of radiation in this disease.