Age Related Macular Degeneration
Conditions
Keywords
age-related macular degeneration, AMD, rheohemapheresis, plasma filtration, electroretinography, ERG, multifocal ERG, double plasma filtration
Brief summary
In this research rheohemapheresis will be used for the treatment of patients with high-risk dry form of age-related macular degeneration. Correction of rheologic parameters and activation of retinal functional reserves after the therapy will positively influence functional condition of retina. The newest special electrophysiologic methods will be used to determine retinal changes in time. The investigators will also evaluate some important immunologic factors and complement changes as well as define indication criteria more precisely.
Detailed description
With optimized therapeutic protocol we would prevent progression of the dry form of AMD into its devastating wet form and stabilize the situation. We suppose that retinal morphologic and functional conditions would improve in a high percentage of patients. Also possible technical and economic savings would not be less important with our own therapeutic protocol, especially, when blindness could be prevented.
Interventions
PROCEDURErheohemapheresis
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with AMD in the stage of soft drusen, grade 1-3 according to European Eye Study (EURYEYE) (see reference No 1), body weight over 50 Kilo and with other feasible indications for aphereses therapy (peripheral veins allowing vascular access to establish the extracorporal circuit). \-
Exclusion criteria
* Study eye with exudative AMD * Study eye with concomitant retinal or choroidal disorder other than AMD * Study eye with significant central lens opacities and/or conditions that limit the view of the fundus * uncontrolled diabetes, uncontrolled arterial hypertension * insufficient antecubital venous access * haemato-oncological malignancies * patients who are unwilling to adhere to visit examination schedules . poor general condition (serious diseases - infections,cardiovascular or cerebral insufficience, severe IHD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroretinography | 2.5 years | Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunologic parameters changes | 2.5 years | To verify till undescribed changes of complement, some cytokines,factors monitoring endothelial function, and apoptosis markers, important for rapid repair of retinal revitalization. |
Countries
Czechia
Outcome results
None listed