Treatment of AMD With Rheohemapheresis /RHF/

NCT01943396 | Unknown Phase 4

• 2 other identifiers: FNHK2013/01IGA-NT14037-4/2013
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

age-related macular degeneration; AMD; rheohemapheresis; plasma filtration; electroretinography; ERG; multifocal ERG; double plasma filtration

Outcome Measures

Primary Outcomes (1)

• Electroretinography

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

  2.5 years

Secondary Outcomes (1)

• immunologic parameters changes

  2.5 years

Study Arms (2)

Rheohemapheresis

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.

Procedure: rheohemapheresis

without rheohemapheresis

NO INTERVENTION

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

Interventions

rheohemapheresis PROCEDURE

Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.

Also known as: rheopheresis, double plasma filtration, cascade filtration

Rheohemapheresis

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

Faculty Hospital

Hradec Králové, 50005, Czechia

Location

Related Publications (12)

• Augood C, Fletcher A, Bentham G, Chakravarthy U, de Jong PT, Rahu M, Seland J, Soubrane G, Tomazzoli L, Topouzis F, Vioque J, Young I. Methods for a population-based study of the prevalence of and risk factors for age-related maculopathy and macular degeneration in elderly European populations: the EUREYE study. Ophthalmic Epidemiol. 2004 Apr;11(2):117-29. doi: 10.1076/opep.11.2.117.28160.

  PMID: 15255027 BACKGROUND

• Blaha M, Cermanova M, Blaha V, Blazek M, Maly J, Siroky O, Solichova D, Filip S, Rehacek V. Safety and tolerability of long lasting LDL-apheresis in familial hyperlipoproteinemia. Ther Apher Dial. 2007 Feb;11(1):9-15. doi: 10.1111/j.1744-9987.2007.00450.x.

  PMID: 17309569 BACKGROUND

• Blaha M, Zadak Z, Blaha V, Andrys C, Havel E, Vyroubal P, Blazek M, Filip S, Lanska M, Maly J. Extracorporeal LDL cholesterol elimination (25 years of experience in CZ). Atheroscler Suppl. 2009 Dec 29;10(5):17-20. doi: 10.1016/S1567-5688(09)71804-5.

  PMID: 20129368 BACKGROUND

• Borberg H. 26 years of LDL--apheresis: a review of experience. Transfus Apher Sci. 2009 Aug;41(1):49-59. doi: 10.1016/j.transci.2009.05.013. Epub 2009 Jun 25.

  PMID: 19559652 BACKGROUND

• Klein R, Klein BE, Knudtson MD, Meuer SM, Swift M, Gangnon RE. Fifteen-year cumulative incidence of age-related macular degeneration: the Beaver Dam Eye Study. Ophthalmology. 2007 Feb;114(2):253-62. doi: 10.1016/j.ophtha.2006.10.040.

  PMID: 17270675 BACKGROUND

• Friedman E. The pathogenesis of age-related macular degeneration. Am J Ophthalmol. 2008 Sep;146(3):348-9. doi: 10.1016/j.ajo.2008.05.017. No abstract available.

  PMID: 18724980 BACKGROUND

• Klingel R, Fassbender C, Fassbender T, Gohlen B. Clinical studies to implement Rheopheresis for age-related macular degeneration guided by evidence-based-medicine. Transfus Apher Sci. 2003 Aug;29(1):71-84. doi: 10.1016/S1473-0502(03)00101-0.

  PMID: 12877897 BACKGROUND

• Klingel R, Fassbender C, Heibges A, Koch F, Nasemann J, Engelmann K, Carl T, Meinke M, Erdtracht B. RheoNet registry analysis of rheopheresis for microcirculatory disorders with a focus on age-related macular degeneration. Ther Apher Dial. 2010 Jun;14(3):276-86. doi: 10.1111/j.1744-9987.2010.00807.x.

  PMID: 20609179 BACKGROUND

• Koss MJ, Kurz P, Tsobanelis T, Lehmacher W, Fassbender C, Klingel R, Koch FH. Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration. Dry AMD treatment with Rheopheresis Trial-ART. Graefes Arch Clin Exp Ophthalmol. 2009 Oct;247(10):1297-306. doi: 10.1007/s00417-009-1113-7. Epub 2009 Jul 23.

  PMID: 19629514 BACKGROUND

• Rencová E., Bláha M., Rozsíval ry form age related macular degeneration with rheohemotherapy. (In Czech.) In Trendy soudobé oftalmologie 7. Praha: Galén, 2011, s. 16-31. ISBN 978- 80-7262- 691-5.

  BACKGROUND

• Rencova E, Blaha M, Studnicka J, Blazek M, Blaha V, Dusova J, Maly J, Kyprianou G, Vasatko T, Langrova H. Haemorheopheresis could block the progression of the dry form of age-related macular degeneration with soft drusen to the neovascular form. Acta Ophthalmol. 2011 Aug;89(5):463-71. doi: 10.1111/j.1755-3768.2009.01710.x. Epub 2010 Jan 22.

  PMID: 20102350 BACKGROUND

• Troutbeck R, Al-Qureshi S, Guymer RH. Therapeutic targeting of the complement system in age-related macular degeneration: a review. Clin Exp Ophthalmol. 2012 Jan-Feb;40(1):18-26. doi: 10.1111/j.1442-9071.2011.02581.x.

  PMID: 22304025 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Milan Blaha, Prof, MD

  Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CZ (1)