HELP Therapy for Dry AMD (HELPuc)

B. Braun

Status: Completed

Conditions: Non-exudative (Dry) Age-related Macular Degeneration (AMD)

Treatments: Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840683

BA-I-H-1202

Details and patient eligibility

About

This is an open-label, single center clinical investigation to evaluate the efficacy and safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14 clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36 weeks and 52 weeks after the final H.E.L.P. therapy session.

Enrollment: 22 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of non-exudative (dry) AMD
• Male or female, between 50 and 90 years
• Presence of soft, confluent drusen in study eye
• At least one large (>125 μm) drusen
• Visual acuity (VA) between 20/32 and 20/100 Early treatment Diabetic Retinopathy Study (ETDRS) vision
• Fibrinogen level >100mg/dL
• Willing to continue lipid-lowering medication throughout the treatment phase if such medication was taken already before the study
• Willing to continue regular supplemental intake of Age related Eye Disease Study (AREDS) vitamins or comparable supplements throughout the study course
• Written informed consent

Exclusion Criteria (related to the underlying disease):

• Any evidence of wet AMD in either eye
• History of treatment for wet AMD in either eye
• Geographic atrophy involving fovea in study eye
• Fellow eye <20/400 VA
• Presence of cataract requiring treatment during study
• Presence of glaucoma requiring new treatment during study
• Presence of diabetic or other vascular retinopathy
• Previous retinal laser or surgical therapy
• Epiretinal membrane in study eye
• Any other ocular condition requiring therapy during the study

Exclusion Criteria (General):

• Participation in another clinical trial within 30 days
• Concurrent participation in another clinical trial
• Pregnancy or lactation
• Inability to give or understand informed consent
• Inability to maintain treatment and follow-up schedule
• Hypersensitivity to fluorescein
• Test positive for infectious status from HIV-, HBV- and HCV- infection

Exclusion Criteria (H.E.L.P. Apheresis):

• Heparin intolerance
• Heparin induced thrombocytopenia (HIT) II
• Hemorrhagic diathesis
• Ulcers in the gastrointestinal area
• Hemorrhage
• Coagulation disorder and neoplasm
• Liver diseases
• Severe heart failure and valvular defect
• Condition following apoplexia
• Dementia
• During pregnancy and lactation
• C1 esterase inhibitor deficiency or hereditary complement component 3 (C3) deficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)

Experimental group

Description:

A total of 8 apheresis therapies with the H.E.L.P. Plasmat Futura System will be performed over a period of 12 weeks.

Treatment:

Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)