EMA Endorses Macustar's Work on Early AMD Clinical Trials

The European Medicines Agency (EMA) has issued its third 'Letter of Support' to the Macustar consortium, a European public-private partnership focused on advancing clinical trial methodologies for early-stage age-related macular degeneration (AMD). This endorsement follows the consortium’s 4-year study involving over 600 European participants with early AMD. The EMA recognized the high quality and significant impact of Macustar's findings, according to a University Hospital Bonn (UKB), Germany, news release. 

The Macustar study seeks to identify eye examinations that can predict disease progression and serve as reliable endpoints for future clinical trials in intermediate AMD. The study employs high-resolution retinal imaging, a broad range of visual function tests, and patient-reported outcome measures. Notably, assessments of vision under low-light and low-contrast conditions—areas where early AMD symptoms are most pronounced—are a key focus of the research.

With a cohort of 619 patients across 20 clinical centers in seven European countries, Macustar represents the largest systematic study on intermediate AMD to date. This observational study not only tracks anatomical changes but also integrates patient-relevant measures, offering a holistic understanding of the disease’s progression.

After 4 years of follow-up, Macustar researchers have uncovered critical insights into how AMD progresses, according to UKB. By analyzing data from advanced imaging technologies like optical coherence tomography (OCT) and fundus-controlled perimetry, the consortium confirmed the importance of combining structural and functional assessments in early AMD diagnosis and prognosis.

Another notable discovery involves patient-reported outcomes. The Vision Impairment in Low Luminance (VILL) questionnaire proved effective in predicting the progression to advanced AMD stages over 4 years. This underscores the value of incorporating patients’ subjective experiences into clinical evaluations.

The EMA’s support validates the Macustar findings, particularly the use of imaging and visual function tests to stratify intermediate AMD into subcategories. This paves the way for more precise clinical trial designs and earlier intervention strategies. The Macustar consortium will deepen its analysis of existing data while continuing to collect 6-year follow-up results. The extended study period will enable researchers to refine clinical endpoints and further characterize intermediate AMD over time.