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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00443911
Other study ID # LBI-06-053-0406
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received March 5, 2007
Last updated June 23, 2011
Start date March 2007
Est. completion date May 2012

Study information

Verified date June 2011
Source The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date May 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 ยด. 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Rudolf Foundation Clinic, Department of Ophthalmology Vienna

Sponsors (1)

Lead Sponsor Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

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