MACUSTAR Receives EMA Support for AMD Clinical Study
Key Insights
The MACUSTAR study received a third letter of support from the EMA for developing outcome measures for clinical trials of age-related macular degeneration (search) (AMD (search)) treatments.
The EMA's support is based on MACUSTAR's 4-year study results involving over 600 European participants with early-stage AMD (search) at high risk of visual impairment.
The study evaluated eye examinations, including retinal imaging and visual function tests, to predict disease progression and serve as potential endpoints for AMD (search) interventional trials.
The MACUSTAR study has received a third letter of support from the European Medicines Agency (EMA) for its work in developing outcome measures for clinical trials focused on treatments for age-related macular degeneration (search) (AMD (search)). The EMA's support is grounded in the study's 4-year results, which included data from over 600 European individuals in the early stages of AMD who were identified as being at high risk of developing visual impairment, according to a release from the European Clinical Research Infrastructure Network (ECRIN (search)).
The MACUSTAR study is designed to evaluate which eye examinations can effectively predict the progression of AMD (search) and serve as potential endpoints for future interventional trials targeting intermediate AMD. The evaluations include high-resolution retinal imaging technologies, a detailed set of visual functional tests, and instruments to assess patient-reported outcomes. The study also assessed vision under reduced lighting conditions and different contrast settings, as these typically show the most noticeable changes in early AMD stages.
The core of the study comprised 619 patients with early and intermediate AMD (search) across seven European countries. The primary aim was to identify high-risk markers of progression from intermediate to late-stage AMD and to use these markers to develop improved trial designs. Participants have completed up to four years of follow-up examinations, and researchers have been analyzing the data to identify new methods for identifying high-risk patients.
The EMA has recognized the high quality and potential impact of the scientific outputs from the MACUSTAR study. ECRIN (search) noted that the study findings could potentially impact more than 200 million patients with AMD (search) worldwide. The additional letter of support will enable researchers to continue conducting more in-depth analyses of the study data, further refining their understanding of AMD progression and potential therapeutic targets.