Trial record 1 of 1 for:    NCT01840683
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HELP Therapy for Dry AMD (HELPuc)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by B.Braun Avitum AG
Sponsor:
Information provided by (Responsible Party):
B.Braun Avitum AG
ClinicalTrials.gov Identifier:
NCT01840683
First received: April 5, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Non-exudative (Dry) Age-related Macular Degeneration (AMD)
Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single Center Study 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)

Resource links provided by NLM:


Further study details as provided by B.Braun Avitum AG:

Primary Outcome Measures:
  • To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA) in patients with non-exudative (dry) AMD. [ Time Frame: Change from Baseline in the best corrected visual acuity (BCVA) at Week 24 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of H.E.L.P. therapy on the change in drusen area as assessed by colour photography. [ Time Frame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF). [ Time Frame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. therapy on overall visual functioning as assessed by the Visual Functioning Questionnaire (VFQ)-25 test. [ Time Frame: Change from Baselineto Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the safety of H.E.L.P. therapy by assessing laboratory tests and vital signs. [ Time Frame: Baseline and at all HELP therapy sessions being conducted after Baseline within 12 weeks. ] [ Designated as safety issue: Yes ]
  • To evaluate the effects of H.E.L.P. on the integrity of the outer retinal bands as assessed by Optical Coherence Tomography (OCT) [ Time Frame: Change from Baseline in integrity of the outer retinal bands at Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA). [ Time Frame: Change from Baseline to Week 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. therapy on the AREDS severity scale as assessed by colour photography. [ Time Frame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. therapy on the incidence and change in area of geographic hypo autofluorescence as assessed by fundus autofluorescence images. [ Time Frame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the effects of H.E.L.P. on the drusen volume as assessed by Optical Coherence Tomography (OCT) [ Time Frame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy ] [ Designated as safety issue: No ]
  • To evaluate the safety of H.E.L.P. therapy by assessing adverse events (AEs). [ Time Frame: At all H.E.L.P. therapy sessions and follow-up visits being conducted after Baseline within 12 weeks and 12, 24, 36 and 52 weeks after completion of the H.E.L.P. therapy. ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of H.E.L.P. therapy by physical examination. [ Time Frame: At all H.E.L.P. therapy sessions being conducted after Baseline within 12 weeks and 52 weeks after completion of the H.E.L.P. therapy. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
Other Name: Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840683

Contacts
Contact: Fareed Ali, MD, FRCS(C) +1-905-212-9482 research@retinamd.ca
Contact: Narendra Armogan, MD, FRCS(C) +1-905-212-9482 ext 234 nancy.davis@retinamd.ca

Locations
Canada, Ontario
Canadian Centre for Advanced Eye Therapeutics Inc. Recruiting
Mississauga, Ontario, Canada, L4W 1W9
Contact: Fareed Ali, MD, FRCS(C)    1-905-212-9482 ext 234    research@retinamd.ca   
Contact: Narendra Armogan, MD, FRCS(C)    1-905-212-9482 ext 234    nancy.davis@retinamd.ca   
Principal Investigator: Fareed Ali, MD, FRCS(C)         
Sub-Investigator: Narendra Armogan, MD, FRCS(C)         
Sponsors and Collaborators
B.Braun Avitum AG
Investigators
Principal Investigator: Fareed Ali, MD, FRCS(C) Canadian Centre for Advanced Eye Therapeutics Inc.
  More Information

No publications provided

Responsible Party: B.Braun Avitum AG
ClinicalTrials.gov Identifier: NCT01840683     History of Changes
Other Study ID Numbers: BA-I-H-1202
Study First Received: April 5, 2013
Last Updated: May 6, 2013
Health Authority: Canada: Health Canada

Keywords provided by B.Braun Avitum AG:
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)

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014