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

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ClinicalTrials.gov Identifier: NCT00443911
Recruitment Status : Unknown
Verified June 2011 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2007
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Phase
Age-related Macular Degeneration Phase 3

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.

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : March 2007
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

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

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

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