AdaptDx Used in EU Study
Dark Adaptation Testing with AdaptDx Selected for Functional Assessment in Large EU Study
Five-Year MACUSTAR Study Aimed at Clinical Validation of Endpoints for AMD
MIDDLETOWN, PENNSYLVANIA, USA, April 11, 2018 – MacuLogix, Inc., announces that the AdaptDx® has been selected as a functional testing device for candidate clinical endpoint development in the MACUSTAR project, a 5-year study aimed at exploring novel outcome measures for future interventional trials in patients with intermediate AMD. The investigation, which is currently funded with more than 16 million euros from the European Innovative Medicines Initiative, will enroll 750 patients in seven countries across Europe. The University of Bonn is coordinating the MACUSTAR consortium of the 20 clinical sites across Europe that will enroll patients in the MACUSTAR research.
Evidence shows that patients with AMD often experience night vision problems early in the disease process, but these functional symptoms cannot be detected or measured using either conventional high luminance visual acuity testing or the latest high-resolution structural imaging technology. The only commercially available automated dark adaptometer, the AdaptDx®, will be used at all 20 MACUSTAR study sites. It works by measuring a patient’s Rod Intercept (RI) time, which is the number of minutes it takes for the eye to adapt from bright light to darkness.
“MacuLogix is proud to be included in this groundbreaking research,” said MacuLogix Co-Founder and Chief Technology Officer Greg Jackson, PhD.
About the MACUSTAR Consortium
The MACUSTAR consortium receives funding from the Innovative Medicines Initiatives 2 joint venture under grant agreement No. 116076. This joint venture is supported by the European Union’s Horizon 2020 Framework Program for Research and Innovation and EFPIA. MACUSTAR is a five-year investigation, with initial study results expected to be released in 2019.
The research project will be conducted at 20 clinical study centers in Europe, including the University Eye Clinic Bonn and the GRADE Reading Center Bonn, the Moorfields Eye Hospital, the University College, the City University, the Fondation voir et entendre Paris, the Coimbra Association for Innovation and Biomedical Research on Light and Image (AIBILI), the Radound University Medical Center, the University of Sheffield and the European Clinical Research Infrastructures Network (ECRIN) Paris, as well as the companies Bayer AG, Novartis Pharma AG, Carl Zeiss-Meditec and F. Hoffmann La-Roche. Visit https://www.macustar.eu/ for additional information.
MacuLogix, Inc. equips eye care professionals with the instrument, tools and education needed to effectively diagnose and treat patients with AMD. By leveraging the science of dark adaptation through its AdaptDx®, MacuLogix is working to eliminate preventable blindness caused by AMD, a chronic, progressive disease that impacts over 170 million people worldwide and goes undiagnosed in 25 percent of patients. Through its AdaptDx® dark adaptation biomarker, MacuLogix enables eye care professionals to detect, monitor and treat AMD three years before it can be seen clinically. MacuLogix provides in-practice training and treatment best practices to support the implementation and optimization of the AdaptDx®.