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Completed

NCT Number: NCT00751361

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

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.

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Key information

Conditions

Dry Age Related Macular Degeneration

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Frankfurt Department of Ophthalmology

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rheopheresis / double filtration plasmapheresis

Device

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

Other names: Rheopheresis, Double filtration plasmapheresis

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Apheresis Research Institute

Other

Registry information

Official study title

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

Acronym: ART

Important dates

Study start
1998
Primary completion
2003
Study completion
2003
First posted
Sep 11, 2008
Registry last updated
Sep 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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