Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443911
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2007-03-05
Brief Title:
Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration
Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Organization:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study Overview
Official Title:
Rheohemapheresis and Lutein Supplementation Xantophyll Carotenoid in the Non-Exsudative Form of Age-Related Macular Degeneration
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReLux-AMD
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 degenerationMost 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
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 filteredGeneral 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None