HELP Therapy for Dry AMD

NCT ID: NCT01840683

Last Updated: 2016-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-11-30

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-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.

Conditions

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

Keywords

Age-Related Macular Degeneration (AMD); Age Related Eye Disease Study (AREDS); Best-Corrected Visual Acuity (BCVA); Early Treatment Diabetic Retinopathy Study (ETDRS); Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation (HELP); Visual Function Questionnaire (VFQ)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation

Eligibility 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

• 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

• 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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.Braun Avitum AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fareed Ali, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Canadian Centre for Advanced Eye Therapeutics Inc.

Locations

Canadian Centre for Advanced Eye Therapeutics Inc.

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

BA-I-H-1202

Identifier Type: -

Identifier Source: org_study_id