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Age Related Macular DegenerationPhase 4TARHFNCT01943396

Treatment of AMD With Rheohemapheresis /RHF/

A Phase 4 study testing rheohemapheresis in people with Age Related Macular Degeneration, run by University Hospital Hradec Kralove at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 85 years
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
rheohemapheresis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCzechia
Study dates
Sep 2013to Sep 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
  • -

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Czechia1 site

  • Faculty Hospital

    Hradec Králové, 50005

Other trials in Czechia

About this study

Official title: Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)

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.

Read the 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.

Being tested
rheohemapheresis
Keywords
age-related macular degeneration, AMD, rheohemapheresis, plasma filtration, electroretinography, ERG, multifocal ERG, double plasma filtration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rheohemapheresisProcedure or surgery

    Also called rheopheresis, double plasma filtration, cascade filtration

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

Study groups in NCT01943396
Study groupRoleWhat they receive
RheohemapheresisExperimentalEach 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.
Receives: Procedure: rheohemapheresis
without rheohemapheresisNo interventionInto the group the patients will be randomized with the same disease but without rheohemapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electroretinography

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

    Measured: 2.5 years

Secondary outcomes (1)

  1. 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.

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2016
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01943396
Sponsor's protocol ID
FNHK2013/01
Other IDs
IGA-NT14037-4/2013
Acronym
TARHF
Status last verified
May 2016
First submitted
20 Jun 2013
Last updated
1 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15255027

  • 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.

    PubMed 17309569

  • 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.

    PubMed 20129368

  • 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.

    PubMed 19559652

  • 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.

    PubMed 17270675

  • 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.

    PubMed 18724980

  • 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.

    PubMed 12877897

  • 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.

    PubMed 20609179

  • 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.

    PubMed 19629514

  • 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.

  • 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.

    PubMed 20102350

  • 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.

    PubMed 22304025

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rheohemapheresis in people with Age Related Macular Degeneration, run by University Hospital Hradec Kralove at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electroretinography (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01943396, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.

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