Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial

NCT ID: NCT00751361

Last Updated: 2008-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2003-01-31

Brief Summary

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Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.

Detailed Description

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Conditions

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Dry Age Related Macular Degeneration

Keywords

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Rheopheresis Dry Age Related Macular Degeneration AMD apheresis microcirculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks

Group Type ACTIVE_COMPARATOR

Rheopheresis / double filtration plasmapheresis

Intervention Type DEVICE

Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.

2

No treatment control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rheopheresis / double filtration plasmapheresis

Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.

Intervention Type DEVICE

Other Intervention Names

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Rheopheresis Double filtration plasmapheresis

Eligibility Criteria

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Inclusion Criteria

* 50 to 85 years old
* diagnosis of AMD in both eyes
* must have dry AMD in the study eye
* Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
* peripheral veins allowing vascular access to establish the extracorporal circuit.

Exclusion Criteria

* other retinal or choroidal disorders than AMD
* optic nerve disease, glaucoma
* conditions that limit the view of the fundus
* acute bleeding in any eye


* anaemia
* haemorrhagic diathesis or coagulopathy
* diabetes
* serious acute or chronic kidney or liver failure
* hypotension systolic \< 100 mmHg
* chronic viral infection (HIV, hepatitis B, C)
* epilepsia, psychosis or dementia
* a malignant disease or any other condition with life expectancy \< 12 months
* known history of alcohol or drug abuse and long term serious nicotine abuse
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apheresis Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Apheresis Research Institute

Principal Investigators

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Frank HJ Koch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Frankfurt

Locations

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University of Frankfurt Department of Ophthalmology

Frankfurt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AR-2000

Identifier Type: -

Identifier Source: org_study_id