Status:
UNKNOWN
Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration
Lead Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
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 concent...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00443911
Start Date
March 1 2007
End Date
May 1 2012
Last Update
June 27 2011
Active Locations (1)
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1
Rudolf Foundation Clinic, Department of Ophthalmology
Vienna, Vienna, Austria, 1030