Treatment of AMD With Rheohemapheresis /RHF/ (TARHF)

May 30, 2016 updated by: Karel Antos, University Hospital Hradec Kralove

Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroretinography
Time Frame: 2.5 years
Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Milan Blaha, Prof, MD, Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 30, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNHK2013/01
  • IGA-NT14037-4/2013 (Other Grant/Funding Number: IGA, Ministry of Health, CZ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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