Treatment of AMD With Rheohemapheresis /RHF/
This trial is active, not recruiting.
|Condition||age related macular degeneration|
|Sponsor||University Hospital Hradec Kralove|
|Start date||September 2013|
|End date||May 2016|
|Trial size||36 participants|
|Trial identifier||NCT01943396, FNHK2013/01, IGA-NT14037-4/2013|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (outcomes assessor)|
time frame: 2.5 years
immunologic parameters changes
time frame: 2.5 years
Male or female participants up to 85 years old.
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)
|Official title||Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)|
|Principal investigator||Milan Blaha, Prof, MD|
|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.|
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