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

Age-related Macular Degeneration Clinical Trial

— ReLux-AMD  

Official title:

Rheohemapheresis and Lutein Supplementation (Xantophyll Carotenoid) in the Non-Exsudative Form of Age-Related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00443911
• Other study ID #: LBI-06-053-0406
• 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
• 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 ´. 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

• Age-related Macular Degeneration
• Macular Degeneration

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,