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Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration (ReLux-AMD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00443911
First received: March 5, 2007
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

Age-related macular degeneration is one of the major causes of blindness in the western world. There is an exsudative and a non-exsudative form of age-related macular degeneration.Most studies concentrate on the exsudative form. In the non-exsudative form the policy is generally watch and see, but patients are at risk to develop an exsudative form. So far, the only accepted therapy to reach stable disease in the non-exsudative form is high-dose supplementation of antioxidants. Another approach to improve visual acuity in patients with non-exsudative form of macular degeneration is rheohemapheresis treatment, an extracorporeal therapy where plasma is separated from blood cells. By the use of a hollow fiber filter plasma is depleted of high molecular weight proteins and reinfused. Others report describe the supplementation of lutein (a vitamin A derivative) as possible treatment option. However, none of the studies have yet examined a combination of rheohemapheresis and lutein supplementation.


Condition Phase
Age-related Macular Degeneration
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rheohemapheresis and Lutein Supplementation (Xantophyll Carotenoid) in the Non-Exsudative Form of Age-Related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: May 2012
Detailed Description:

Rheohemapheresis will be performed in 5 cycles. One cycle consists of 2 rheohemapheresis treatments on day 1 and day 4. A cycle lasts for 4 weeks and will be repeated every fourth week. During each treatment > 75% to 100% of patients total plasma volume has to be filtered.General medical reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with OCT 3, autofluorescein imaging and infrared imaging, multifocal ERG, ocular echography, and blood examinations will be performed.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-exudative AMD

Criteria

Inclusion Criteria:

  • Study eye with non-exsudative AMD AREDS II - III

    • with > 10 large soft, and / or confluent drusen within 3000 nm of the foveal centre
    • and a best corrected visual acuity of 0.06 - 1.0 using ETDRS charts (letter score of 3 to 50 letters)
    • with / without geographic atrophy less than 3 disc diameters within 3000 nm of the foveal centre ´. with / without serous pigment epithelial detachment without clearly identifiable neovascularisation
  • Patients must have elevated baseline concentrations of at least one of the rheologic parameters (serum cholesterol level > 200 mg/dL, fibrinogen level > 390 mg/dL, or plasmaviscosity > 1.6 mPa*s)
  • Men or women aged between 50 - 99 years.

Exclusion Criteria:

  • Study eye with exsudative 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
  • poor general condition
  • hematocrit < 30%
  • coagulation disorders (incl. marcoumar therapy)
  • significant cardiac problems ( > NYHA II)
  • history (< 12 months) of cardiac infarction
  • uncontrolled arterial hypertension
  • recent history (< 3 months) of cerebral vascular infarction
  • cerebrovascular disease IV
  • uncontrolled diabetes
  • insufficient antecubital venous access
  • lutein supplementation within the last 3 months
  • weight < 45 kg
  • hemato-oncological disorder
  • Patients who are unwilling to adhere to visit examination schedules
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443911

Locations
Austria
Rudolf Foundation Clinic, Department of Ophthalmology
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Katharina E Kubista, MD LBI
  More Information

No publications provided

Responsible Party: Prof.Dr. Susanne Binder, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
ClinicalTrials.gov Identifier: NCT00443911     History of Changes
Other Study ID Numbers: LBI-06-053-0406
Study First Received: March 5, 2007
Last Updated: June 23, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration, rheopheresis, lutein

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013