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| ID | Type | Description | Link |
|---|---|---|---|
| IGA-NT14037-4/2013 | Other Grant/Funding Number | IGA, Ministry of Health, CZ |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| without rheohemapheresis | No Intervention | Into the group the patients will be randomized with the same disease but without rheohemapheresis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rheohemapheresis | Procedure | Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electroretinography | Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| immunologic parameters changes | To verify till undescribed changes of complement, some cytokines,factors monitoring endothelial function, and apoptosis markers, important for rapid repair of retinal revitalization. | 2.5 years |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Milan Blaha, Prof, MD | Charles University, Medical Faculty and Faculty Hospital, 50005 Hradec Kralove, CZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital | Hradec Králové | 50005 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15255027 | Background | 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. | |
| 17309569 |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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|
| 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. |
| 20129368 | 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. |
| 19559652 | 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. |
| 17270675 | 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. |
| 18724980 | 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. |
| 12877897 | 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. |
| 20609179 | 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. |
| 19629514 | 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. |
| 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. |
| 20102350 | 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. |
| 22304025 | 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. |
| D013514 | Surgical Procedures, Operative |