Macustar project seeks novel endpoints
In order to prevent or delay the progression of intermediate age-related macular degeneration (iAMD) to late-stage AMD, the functional deficit in iAMD must first be characterised,” said Professor Frank Holz MD, University Eye Clinic Bonn, Germany. “This is the goal of the MACUSTAR project, to seek novel clinical endpoints for clinical trials in iAMD so that interventional studies can be implemented.”
Dr Holz and his colleague, Professor Robert Finger MD, also of Bonn, brought delegates up to speed regarding the ongoing MACUSTAR project at the 18th EURETINA Congress on Thursday. MACUSTAR is one of many multicentre trials now under way under the guidance of EVICR.net, and is funded by the European Innovative Medicines Initiative (IMI), the world’s largest public-private partnership in life sciences.
“AMD is a progressively degenerative disease than can lead to the advanced stages of neovascular AMD and geographic atrophy,” said Dr Holz. “Despite a prevalence of approximately 15 per cent in people over the age of 55 years, there are no available treatments to counteract the progression of iAMD.” The goal of MACUSTAR is to develop clinical endpoints in three main categories: function, structure (imaging) and patient-reported outcomes.
“Functional testing in MACUSTAR is used to identify and validate visual function outcomes that reliably capture the functional impairment in iAMD and to establish the discriminatory power of these variables in relation to disease classification in AMD,” said Dr Finger. “Should data analysis show any of these tests to be unreliable or have low discriminatory power, they will be removed.”
Structural endpoints will be determined by both standard retinal imaging, such as OCT, fundus photography and fluorescein angiography, and innovative imaging modalities such as quantitative autofluorescence, OCT-angiography and swept-source OCT.
Candidate endpoints include scotopic microperimetry, dark adaptation, contrast sensitivity and the implementation of a specifically developed patient-report outcome measure: the Vision Impairment in Low Luminance (VILL) questionnaire. This questionnaire covers areas such as reading, mobility, safety and socio-emotional well-being, all with a focus on light conditions such as low contrast and low luminance that become particularly challenging for people with iAMD.
Recruitment will continue until February 2019, with the goal of including 750 patients: 600 patients with intermediate AMD; 50 with no abnormalities (or normal ageing changes); 50 with early AMD and 50 with late AMD. These patients will be followed up for three years.