Overview

This trial is active, not recruiting.

Condition age related macular degeneration
Treatment rheohemapheresis
Phase phase 4
Sponsor University Hospital Hradec Kralove
Start date September 2013
End date May 2016
Trial size 36 participants
Trial identifier NCT01943396, FNHK2013/01, IGA-NT14037-4/2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
rheohemapheresis rheopheresis
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
(No Intervention)
Into the group the patients will be randomized with the same disease but without rheohemapheresis

Primary Outcomes

Measure
Electroretinography
time frame: 2.5 years

Secondary Outcomes

Measure
immunologic parameters changes
time frame: 2.5 years

Eligibility Criteria

Male or female participants up to 85 years old.

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)

Additional Information

Official title Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)
Principal investigator Milan Blaha, Prof, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital Hradec Kralove.