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

Apheresis Research Institute

Status and phase: Completed; Phase 4

Conditions: Dry Age Related Macular Degeneration

Treatments: Device: Rheopheresis / double filtration plasmapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT00751361

AR-2000

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Active Comparator group

Description:

Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks

Treatment:

Device: Rheopheresis / double filtration plasmapheresis

2

No Intervention group

Description:

No treatment control group