MAKUSTAR – DMAE intermediate level. Development of new variables for clinical trials in patients

MAKUSTAR – DMAE intermediate level. Development of new variables for clinical trials involving patients for regulatory purposes to ensure patient access.

age-related macular degeneration (AMD) is the leading cause of significant vision loss and blindness in Europe, affecting almost 30 percent of older people. This chronic disease develops gradually. early AMD to intermediate AMD (iDMAE) and finally AMD in an advanced stage with severe and in many cases irreversible loss of central vision.

Goals MAKUSTAR include characteristics of functional deficit in intermediate AMD (iDMAE) and develop functional, structural, and patient-reported outcome measures specifically for this intermediate stage of disease. In addition, a thorough investigation will be conducted into the fact risk factors that contribute to the progression of intermediate AMD (iAMD) to advanced phase AMD AMD.

Dr Hannah Dunbar works as an optometrist in Moorfields Eye Hospital in London and is researching the effect eye diseases in people’s everyday lives at the UCL Institute of Ophthalmology. IN MAKUSTAR, she studies functional testing in mid-level AMD. To find out more about what motivates Hannah and what we do at MAKUSTARfollow this link.

The MACUSTAR consortium, led by the Department of Ophthalmology at the University Hospital Bonn (UKB), is extending the duration of a European clinical trial aimed at age-related macular degeneration (AMD). His goal is to gain more knowledge about the intermediate variant of the disease, which progresses towards late manifestations associated with vision loss.

age-related macular degeneration (AMD) is characterized by gradual degeneration of photoreceptors located in spotwhich could lead to a decrease Visual acuity. This pathology mainly affects people over 60 years of age, and with increasing life expectancy there is a continuous increase in the number of cases. AMD It develops in early, middle and late stages and can lead to significant vision loss and even blindness.

It is critical to develop new treatments that can slow or stop AMD promotion from intermediate to late phase. Testing new therapeutic approaches in clinical trials requires the development of methods and the identification of biomarkers that provide reliable assessment of efficacy.

Prof. Dr. Frank G. Holtz, Director of the Department of Ophthalmology at UKB

In the center MAKUSTAR An observational study was conducted that included 585 patients with intermediate AMD, involving 20 clinical trial sites located in seven European countries. This study focused on identifying tests predictive of disease progression that could serve as potential endpoints for future intervention studies in intermediate AMD. Among the tests being assessed are technologies high resolution image, a comprehensive suite of functional tests and tools for measuring patient-reported outcomes. In addition to the usual vision tests, vision is tested in low light conditions and various levels of contrast. Research on dark adaptation, reading speed, and orientation is expected to provide further insight into the impact of disease progression on visual function.

This is the largest systematic study conducted to date. intermediate AMD. The main goal of the consortium MAKUSTAR The goal is to determine which parameters or combinations of different markers offer the most effective approach to evaluate new therapeutic strategies to be reviewed by regulatory agencies.

“The baseline assessment and three-year follow-up have already led to significant progress in our understanding of the disease, especially in terms of its heterogeneity and prognostic factors,” explains Professor Dr. Robert Finger.

It is hoped that expansion of this research will improve our understanding of AMD, allow for earlier detection of progression, and facilitate the development of innovative treatments in the future.


UKB Eye Hospital, Reading Center GRADE Bonn, Moorfields Eye Hospital London (MBRC), University College London (UCL), City University London (City) and Fondation Voir et Entender (FVE) Paris, Association for Innovation and Biomedical Research of Light and Image (AIBILI) Coimbra, Radboud University Medical Center (RUMC) in Nijmegen, the University of Sheffield and the European Clinical Research Infrastructure Network (ECRIN) in Paris, as well as Carl Zeiss, Meditec, Bayer AG, Novartis Pharma. AG and F. Hoffmann La-Roche form the macugen consortium.

MAKUSTAR – DMAE intermediate level. Development of new variables for clinical trials in patients

Translation: Retinal macula association


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