Treatment of AMD With Rheohemapheresis /RHF/ (TARHF)
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|ClinicalTrials.gov Identifier: NCT01943396|
Recruitment Status : Unknown
Verified May 2016 by Karel Antos, University Hospital Hradec Kralove.
Recruitment status was: Active, not recruiting
First Posted : September 17, 2013
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Procedure: rheohemapheresis||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||September 2016|
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.
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
No Intervention: without rheohemapheresis
Into the group the patients will be randomized with the same disease but without rheohemapheresis
- Electroretinography [ Time Frame: 2.5 years ]Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods
- immunologic parameters changes [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943396
|Hradec Kralove, Czech Republic, 50005|
|Principal Investigator:||Milan Blaha, Prof, MD||Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ|