EMA Endorses Macustar's Research 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 dedicated to improving clinical trial methodologies for early-stage age-related macular degeneration (AMD). This endorsement follows Macustar’s four-year study, which involved over 600 European participants with early AMD. The EMA acknowledged the high quality and significant impact of the consortium’s findings, as reported by University Hospital Bonn (UKB), Germany.

Advancing Clinical Trials for Early AMD

The Macustar study aims 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

       • Comprehensive visual function tests

       • Patient-reported outcome measures

A key focus of the research is assessing vision under low-light and low-contrast conditions, where early AMD symptoms are most pronounced.

Largest Systematic Study on Intermediate AMD

With 619 patients enrolled across 20 clinical centers in seven European countries, Macustar represents the largest observational study on intermediate AMD to date. By integrating anatomical tracking with patient-relevant measures, the study provides a comprehensive understanding of disease progression.

Key Findings After Four Years of Follow-Up

According to UKB, Macustar researchers have provided critical insights into AMD progression by analyzing data from advanced imaging technologies, such as:

       • Optical Coherence Tomography (OCT)

       • Fundus-Controlled Perimetry

The findings confirm that combining structural and functional assessments is essential for early AMD diagnosis and prognosis.

The Role of Patient-Reported Outcomes

One of the study’s most significant discoveries involves patient-reported outcomes. The Vision Impairment in Low Luminance (VILL) questionnaire proved effective in predicting disease progression over four years, emphasizing the importance of integrating subjective patient experiences into clinical evaluations.

Impact of EMA Support on Future AMD Research

The EMA’s endorsement reinforces the Macustar findings, particularly the use of imaging and visual function tests to stratify intermediate AMD into subcategories. This recognition paves the way for:

       • More precise clinical trial designs

       • Earlier intervention strategies for AMD

Next Steps: Expanding Research on Intermediate AMD

The Macustar consortium will continue analyzing existing data while collecting six-year follow-up results. This extended study period will allow researchers to:

       • Refine clinical endpoints

       • Further characterize intermediate AMD over time

With the support of the EMA, Macustar is shaping the future of early AMD research, providing valuable insights that could lead to earlier and more effective treatments.