Treatment of AMD With Rheohemapheresis /RHF/ (TARHF)

University Hospital Hradec Kralove

Status and phase: Unknown; Phase 4

Conditions: Age Related Macular Degeneration

Treatments: Procedure: rheohemapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT01943396

FNHK2013/01

IGA-NT14037-4/2013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: Under 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Rheohemapheresis

Experimental group

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.

Treatment:

Procedure: rheohemapheresis

without rheohemapheresis

No Intervention group

Description:

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