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

Purpose

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.

Condition	Intervention	Phase
Dry Age Related Macular Degeneration	Device: Rheopheresis / double filtration plasmapheresis	Phase IV

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART

Further study details as provided by Apheresis Research Institute:

Primary Outcome Measures:

The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. [ Time Frame: 30 weeks (7.5 months) ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	November 1998
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks	Device: Rheopheresis / double filtration plasmapheresis Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
2: No Intervention No treatment control group

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

General exclusion criteria for the treatment of Rheopheresis:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751361

Locations


Germany
	University of Frankfurt Department of Ophthalmology
	Frankfurt, Germany, 60590

Sponsors and Collaborators

Apheresis Research Institute

Investigators


Principal Investigator:	Frank HJ Koch, Prof. Dr.	University of Frankfurt

More Information

Responsible Party:	Apheresis Research Institute ( Reinhard Klingel, Prof. Dr. )
Study ID Numbers:	AR-2000
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751361
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Apheresis Research Institute:

Rheopheresis

Dry Age Related Macular Degeneration

AMD

apheresis

microcirculation

Study placed in the following topic categories:

Eye Diseases

Retinal Degeneration

Macular Degeneration

Retinal Diseases

Retinal degeneration

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Apheresis Research Institute
Information provided by:	Apheresis Research Institute
ClinicalTrials.gov Identifier:	NCT00751361