Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Deg… (NCT00443911) | Clinical Trial Compass
UnknownNot Applicable
Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration
Austria20 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00443911
SponsorThe Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery