Amadeus Project
 
 

PLEASE NOTE: Data collection for the Amadeus registry has been terminated.

The Amadeus project (Age related MAcular DEgeneration And MAcular Diabetic Edema USed in patients treated with anti-VEGF treatment in the Czech Republic) is focused on monitoring of patients with age-related macular degeneration (AMD) and diabetic macular edema (DME) who have been treated with anti-VEGF medications.


Objectives of the AMD arm

   

 Primary objectives

  • Description of a standard clinical practice in the treatment of AMD patients in the Czech Republic.
  • Documentation of disease severity at the initial examination and during the treatment.
  • Description of standard diagnostic procedures in individual centres, including the results of examination of visual acuity, fundus of the eye, angiology examination of retinal vessels,
  • Description of standard therapeutic procedures including the dosage, frequency of drug administration, changes in the therapeutic procedure during the treatment.
  • Documentation of conditions under which a primarily chosen therapy is changed.
 

Secondary objectives

  • Documentation of treatment safety and effectiveness at follow-up visits (3, 6, 12, 18 and 24 months after treatment initiation) by monitoring changes in visual acuity.
  • Evaluation of disease activity at follow-up visits (3, 6, 12, 18 and 24 months after treatment initiation).
  • Documentation of disease characteristics leading to the introduction of a specific type of primary (or secondary) therapy.
  • Documentation of safety and effectiveness of a secondary therapy (switch).

Objectives of the DME arm

   

Primary objectives

  • 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 (3, 6, 12, 18 and 24 months after treatment initiation).
 

Secondary objectives

  • Documentation of treatment safety and effectiveness at follow-up visits (3, 6, 12, 18 and 24 months after treatment initiation).
  • Evaluation of therapeutic procedures in specialised centres.

Monitored diagnoses

AMD

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 edema, 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.

example of an image as perceived by a healthy person (source: wikipedia.org) the same image as perceived by an AMD patient (source: wikipedia.org)

 

DME

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 edema (DME). 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 DME 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 edema (DME). Intravitreally administered drugs (corticosteroids) are currently used to treat DME; more recently, inhibitors of the vascular endothelial growth factor (VEGF) have also been applied.

example of an image as perceived by a healthy person (source: wikipedia.org) the same image as perceived by an DME patient (source: wikipedia.org)