Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of AMD With Rheohemapheresis /RHF/ (TARHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Karel Antos, University Hospital Hradec Kralove

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Procedure: rheohemapheresis Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rheohemapheresis
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
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
Other Names:
  • rheopheresis
  • double plasma filtration
  • cascade filtration

No Intervention: without rheohemapheresis
Into the group the patients will be randomized with the same disease but without rheohemapheresis



Primary Outcome Measures :
  1. Electroretinography [ Time Frame: 2.5 years ]
    Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
Layout table for location information
Czech Republic
Faculty Hospital
Hradec Kralove, Czech Republic, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
Layout table for investigator information
Principal Investigator: Milan Blaha, Prof, MD Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ

Publications:
Rencová E., Bláha M., Rozsíval ry form age related macular degeneration with rheohemotherapy. (In Czech.) In Trendy soudobé oftalmologie 7. Praha: Galén, 2011, s. 16-31. ISBN 978- 80-7262- 691-5.

Layout table for additonal information
Responsible Party: Karel Antos, Deputy director, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT01943396     History of Changes
Other Study ID Numbers: FNHK2013/01
IGA-NT14037-4/2013 ( Other Grant/Funding Number: IGA, Ministry of Health, CZ )
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Karel Antos, University Hospital Hradec Kralove:
age-related macular degeneration
AMD
rheohemapheresis
plasma filtration
electroretinography
ERG
multifocal ERG
double plasma filtration

Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases