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

Phase 4

Completed

• Conditions: Dry Age Related Macular Degeneration
• Interventions: Device: Rheopheresis / double filtration plasmapheresis

• Registration Number: NCT00751361
• Lead Sponsor: Apheresis Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Last Update Submitted: 2008-09-10
• Study First Posted: 2008-09-11
• Last Update Posted: 2008-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rheopheresis / double filtration plasmapheresis	Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Frankfurt Department of Ophthalmology; 🇩🇪 Frankfurt, Germany