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Treatment of AMD With Rheohemapheresis /RHF/ (TARHF)

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
rheohemapheresis
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring age-related macular degeneration, AMD, rheohemapheresis, plasma filtration, electroretinography, ERG, multifocal ERG, double plasma filtration

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rheohemapheresis

without rheohemapheresis

Arm Description

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.

Into the group the patients will be randomized with the same disease but without rheohemapheresis

Outcomes

Primary Outcome Measures

Electroretinography
Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods

Secondary Outcome Measures

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.

Full Information

First Posted
June 20, 2013
Last Updated
May 30, 2016
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT01943396
Brief Title
Treatment of AMD With Rheohemapheresis /RHF/
Acronym
TARHF
Official Title
Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
age-related macular degeneration, AMD, rheohemapheresis, plasma filtration, electroretinography, ERG, multifocal ERG, double plasma filtration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rheohemapheresis
Arm Type
Experimental
Arm Description
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.
Arm Title
without rheohemapheresis
Arm Type
No Intervention
Arm Description
Into the group the patients will be randomized with the same disease but without rheohemapheresis
Intervention Type
Procedure
Intervention Name(s)
rheohemapheresis
Other Intervention Name(s)
rheopheresis, double plasma filtration, cascade filtration
Intervention Description
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
Primary Outcome Measure Information:
Title
Electroretinography
Description
Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
immunologic parameters changes
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Blaha, Prof, MD
Organizational Affiliation
Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Hospital
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
15255027
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
19559652
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Treatment of AMD With Rheohemapheresis /RHF/

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