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

NCT00443911 | Unknown

• 1 other identifier: LBI-06-053-0406
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degeneration, rheopheresis, lutein

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-exudative AMD

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Rudolf Foundation Clinic, Department of Ophthalmology

Vienna, Vienna, 1030, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Katharina E Kubista, MD

  LBI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: March 1, 2007
• Study Completion: May 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

AU (1)