Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration - Full Text View

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

This study is currently recruiting participants.

Verified by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, March 2008

Sponsored by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:	NCT00443911

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 III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Lutein Carotenoids

U.S. FDA Resources

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

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

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	20
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009

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

Contacts

Contact: Katharina E Schmid-Kubista, MD	+4317116594674	katharina.schmid-kubista@wienkav.at
Contact: Susanne Binder, MD	+431711654607	susanne.binder@wienkav.at

Locations

Austria
Rudolf Foundation Clinic, Department of Ophthalmology	Recruiting
Vienna, Austria, 1030

Sponsors and Collaborators

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators

Principal Investigator:

Katharina E Schmid-Kubista, MD

LBI

More Information

Responsible Party:	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery ( Prof.Dr. Susanne Binder )
Study ID Numbers:	LBI-06-053-0406
Study First Received:	March 5, 2007
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00443911
Health Authority:	Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

age-related macular degeneration, rheopheresis, lutein

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration

Carotenoids
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009