Clinical trial NCT01943396: Treatment of AMD With Rheohemapheresis /RHF/
Official title: Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Keywords: age-related macular degeneration
AMD
rheohemapheresis
plasma filtration
electroretinography
ERG
multifocal ERG
double plasma filtration
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 36
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

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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)

Primary outcomes:
measure: Electroretinography
timeFrame: 2.5 years
Secondary outcomes:
measure: immunologic parameters changes
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Faculty Hospital
Study officials:
affiliation: Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ
name: Milan Blaha, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.