Treatment of AMD With Rheohemapheresis /RHF/

Study Overview
=================
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.

Official Title
-----------------
Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: rheohemapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rheohemapheresis<br>Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. Best-corrected visual acuity, electroretinography and drusenoid retinal pigment epithelium detachment area will be examined. Changes of selected special immunologic parameters will be measured. | Procedure: rheohemapheresis<br>* Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.<br>* Other names: cascade filtration;|
| No Intervention: without rheohemapheresis<br>Into the group the patients will be randomized with the same disease but without rheohemapheresis | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroretinography | Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunologic parameters changes | To verify till undescribed changes of complement, some cytokines,factors monitoring endothelial function, and apoptosis markers, important for rapid repair of retinal revitalization. | 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, age-related macular degeneration, rheohemapheresis, plasma filtration, electroretinography, ERG, multifocal ERG, double plasma filtration