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

Primary Purpose

Dry Age Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Rheopheresis / double filtration plasmapheresis
Sponsored by
Apheresis Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age Related Macular Degeneration focused on measuring Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Frankfurt Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks

No treatment control group

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2008
Last Updated
September 10, 2008
Sponsor
Apheresis Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00751361
Brief Title
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
Acronym
ART
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Apheresis Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age Related Macular Degeneration
Keywords
Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks
Arm Title
2
Arm Type
No Intervention
Arm Description
No treatment control group
Intervention Type
Device
Intervention Name(s)
Rheopheresis / double filtration plasmapheresis
Other Intervention Name(s)
Rheopheresis, Double filtration plasmapheresis
Intervention Description
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank HJ Koch, Prof. Dr.
Organizational Affiliation
University of Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Frankfurt Department of Ophthalmology
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

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

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