Designing Clinical Trials for Age-Related Geographic Atrophy of the Macula

In Brief Purpose: To derive information from the Geographic Atrophy (GA) Natural History Study that is relevant to recruiting patients and designing clinical trials for GA. Methods: A prospective natural history study with annual follow-up enrolled patients with GA and no choroidal neovascularization (CNV) in at least one eye. Characteristics of recruited and enrolled patients are analyzed, in the context of progression data from the study. Results: The data show that GA from age-related macular degeneration (AMD) was seen in 82% of the referred patients, there was an attrition rate of 14%, and 60% of the patients with GA from AMD had bilateral GA without CNV. Within the 83 patients in the bilateral GA group with follow-up, 50 patients (60%) met both the proposed visual acuity and the proposed GA area criteria for a treatment trial in one or both eyes. Conclusion: These data should be helpful in planning future treatment trials for GA. In the geographic atrophy natural history study, 60% of the patients had bilateral GA without CNV. Within this bilateral GA group, 60% met the proposed visual acuity and atrophic area criteria proposed for a clinical trial for GA.