MACUSTAR receives additional EMA support for AMD clinical study

The core of the study consisted of 619 patients with early and intermediate AMD across seven European countries. Image credit: ©katarzyna – stock.adobe.com

MACUSTAR received a third letter of support from the European Medicines Agency (EMA) for developing outstanding outcome measures for clinical trials testing treatments for age-related degeneration (AMD). The support from the EMA was based on MACUSTAR’s 4-year study results of more than 600 Europeans with early stages of AMD who were at a high risk of developing visual impairment, according to a news release from the European Clinical Research Infrastructure Network (ECRIN).

The MACUSTAR study evaluated which eye examinations predict disease progression and represent potential endpoints for future interventional trials in intermediate AMD. These examinations included high-resolution retinal imaging technologies and a detailed set of visual functional tests and instruments to test patient-reported outcomes. Vision under reduced lighting conditions and different contrast settings was also assessed in the study, as they typically show the most noticeable changes among all tests in early AMD stages.

Additionally, the core of the study consisted of 619 patients with early and intermediate AMD across seven European countries. The aim of testing this many patients was to identify high-risk markers of progression from intermediate AMD to late AMD and to develop trial designs from their results.

While the MACUSTAR study isn’t finished, participants have already completed up to 4 years of follow-up examinations. Researchers from the study have analysed the data from these follow-up examinations over the last 4 years, finding new and innovative ways to identify high-risk patients.

The EMA recognised the high quality and impact of the scientific outputs from MACUSTAR’s study. The study findings could impact more than 200 million patients with AMD globally, ECRIN noted in the news release. The new letter of support will also allow researchers to continue to conduct more in-depth analyses of the study data.

Reference

Evaluation of novel therapy endpoints in age-related macular degeneration supported by European Medicines Agency. European Clinical Research Infrastructure Network. News release. Published January 23, 2025. Accessed January 27, 2025. https://ecrin.org/news/evaluation-novel-therapy-endpoints-age-related-macular-degeneration-supported-european