Treatment of AMD With Rheohemapheresis /RHF/

Phase 4

• Conditions: Age Related Macular Degeneration
• Interventions: Procedure: rheohemapheresis

• Registration Number: NCT01943396
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-06-20
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-17
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-30
• Last Update Posted: 2016-06-01
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rheohemapheresis	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.

Primary Outcome Measures

Name	Time	Method
Electroretinography	2.5 years	Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods

Secondary Outcome Measures

Name	Time	Method
immunologic parameters changes	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.

Trial Locations

Locations (1)

Faculty Hospital; 🇨🇿 Hradec Kralove, Czech Republic