Status:
COMPLETED
HELP Therapy for Dry AMD
Lead Sponsor:
B.Braun Avitum AG
Conditions:
Non-exudative (Dry) Age-related Macular Degeneration (AMD)
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
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-ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01840683
Start Date
May 1 2013
End Date
November 1 2016
Last Update
November 23 2016
Active Locations (1)
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1
Canadian Centre for Advanced Eye Therapeutics Inc.
Mississauga, Ontario, Canada, L4W 1W9