Amadeus

The AMADEUS project was a non-interventional observational study which monitored patients suffering from wet AMD (age-related macular degeneration) or diabetic macular oedema (DMO). The objectives of this multicentre prospective study included improvements in care of AMD and DMO patients, the integration of criteria for treatment monitoring in the Czech Republic, and the establishment of treatment guidelines – specific for the Czech population – which would detect and prevent possible complications with serious consequences.

Age-related macular degeneration (AMD) is the main cause of blindness in patients older than 55 years in developed countries. There are two forms of AMD, “dry form” (atrophic) and “wet form” (exsudative). Despite the fact that the exsudative form is responsible only for 10% of cases of AMD, it is a significant medical issue due to rapid progression of the disease and considerable loss of vision it usually causes.

The exsudative form is characterised by formation of choroid neovascularisation (CNV) which leads to retinal oedema, ischaemia and irreversible destruction of macular photoreceptors. It is common that macular and juxta-macular areas are mainly affected. In number of cases the disease is complicated further by sub-retinal haemorrhage, which in most cases leads to significant vision loss or blindness.

So far, there has been no data available on incidence and prevalence rates of AMD in the Czech Republic. However, based on international epidemiological studies, it can be expected that that the incidence of the wet form of AMD ranges between 1,200 and 1,500 patients per year.

Primary objectives of the AMD arm:

• Evaluation of available AMD therapies in routine clinical practice

Secondary objectives of the AMD arm:

• Evaluation of adherence to guidelines recommended by the Czech Society of Ophthalmology
• Acquisition of data needed to update the guidelines for treatment of AMD patients in the Czech Republic
• Standardisation of therapeutic procedures in participating centres
• Evaluation of safety of monitored drugs
• Cost estimate of wet AMD treatment in a given period

Diabetic retinopathy is the most common microvascular complication of diabetes, and is the leading cause of blindness in the populations of developed countries. Vision loss as an associated condition of diabetes is mostly caused by a diabetic macular oedema (DMO). Despite significant efforts to establish an early diagnosis and to treat diabetes efficiently, almost all patients with type 1 diabetes and more than 60% of patients with type 2 diabetes will develop diabetic retinopathy or DMO within 20 years after the diagnosis. Blindness is caused by the fact that photoreceptors in the centre of macula have been destroyed as a result of the liquid and lipid-based hard exudates present in macula, which form the diabetic macular oedema (DMO). Intravitreally administered drugs (corticosteroids) are currently used to treat DMO; more recently, inhibitors of the vascular endothelial growth factor (VEGF) have also been applied.

Primary objectives of the DMO arm:

• Collection of data from routine clinical practice on DME patients who have been treated with anti-VEGF medications
• Evaluation of disease activity at follow-up visits (at least four times a year)

Secondary objectives of the DMO arm:

• Documentation of treatment safety and effectiveness at follow-up visits (at least four times a year)
• Evaluation of therapeutic procedures in specialised centres

More information on the AMADEUS project:

• Expert guarantor: Assoc Prof Sarka Pitrova, MD, PhD, FEBO; Prof Jiri Rehak, MD, PhD; Assoc Prof Bohdana Kalvodova, MD, PhD
• Funding: Novartis, Ltd., BAYER, Ltd.
• Partners: 12 ophthalmology centres in the Czech Republic (you can find more detailed information on the website of the Amadeus project)
• Brief overview of results: you can find more detailed information on the website of the Amadeus project