A Phase 4 interventional study of rheohemapheresis in Age Related Macular Degeneration, sponsored by University Hospital Hradec Kralove. Status unknown at 1 site in Czech Republic. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by University Hospital Hradec Kralove · Phase 4, Interventional, and Treatment
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 36 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University Hospital Hradec Kralove is the lead sponsor of 46 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Into the group the patients will be randomized with the same disease but without rheohemapheresis
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
Also known as: rheopheresis, double plasma filtration, cascade filtration
Electroretinography
Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods
Time frame: 2.5 years
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.
Time frame: 2.5 years
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Hradec Kralove