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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751361

Acronym

ART

Enrollment

Registered

2008-09-11

Start date

1998-11-30

Completion date

2003-01-31

Last updated

2008-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age Related Macular Degeneration

Keywords

Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation

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.

Interventions

DEVICERheopheresis / double filtration plasmapheresis

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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.	30 weeks (7.5 months)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026