A new natural history study of AMD study, named the “AMD Ryan Initiative Study” (ARIS), in memory of the late Stephen J. Ryan, is scheduled for launch on March 5th, 2018. The study will recruit up to 500 patients over a 5-year period to specifically learn more about the natural history of the disease and will use the latest imaging technology, genetic information and functional vision testing to identify specific biomarkers of disease progression. In addition, researchers at twenty (20) ARIS study sites will track drusen volume changes and SD-OCT changes to determine how such changes might lead to functional changes in visual acuity and dark adaptation.
It is estimated that somewhere between 10 and 20% of patients diagnosed with early AMD progress to late stage AMD within a 5-year period. However, identifying the one-fifth of patients who will progress to the more damaging stages of the disease is a key challenge. The complex and multifactorial nature of the disorder will require a significant collection of data, and data analysis, to uncover the varying genetic and environmental risk factors that tip patients into the late stage bracket. In addition the research should also support the identification of factors that tend to associate with the estimated 80% of early stage sufferers that do not progress to late stage disease within the initial 5-year window. The study will recruit three cohorts of 200, 200 and 100 patients: one group of 200 patients will have a diagnosis of early stage AMD with medium drusen, a further 200 patients will have early reticular pseudo-drusen associated with a higher risk of disease progression and finally a group of 100 age matched drusen-free control participants. All patients will undergo SD-OCT and dark-adapted fundus perimetry and, potentially analysis of participants of DNA to determine if correlations exist between gene sequences and AMD progression.
The clinical study is to be funded by the US National Eye Institute but will include study sites in the United Kingdom, Australia, Germany, Italy and at a number of centers the United States. According to Emily Y. Chew, M.D., Deputy Clinical Director at the US National Eye Institute, “[t]he findings will contribute to our understanding of the underlying biology driving the transition from early to late-stage disease so that therapies can be developed to halt its progression. Treatments that halt the disease at its early stage would have an enormous public health impact.