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

Dry Age Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751361
• Other study ID #: AR-2000
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2008
• Last updated: September 10, 2008
• Start date: November 1998
• Est. completion date: January 2003

Study information

• Verified date: September 2008
• Source: Apheresis Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Age Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Germany	University of Frankfurt Department of Ophthalmology	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Apheresis Research Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No