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HELP Therapy for Dry AMD (HELPuc)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
Sponsored by
B.Braun Avitum AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-exudative (Dry) Age-related Macular Degeneration (AMD) focused on measuring 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)

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canadian Centre for Advanced Eye Therapeutics Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

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.

Secondary Outcome Measures

To evaluate the effects of H.E.L.P. therapy on the change in drusen area as assessed by colour photography.
To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF).
To evaluate the effects of H.E.L.P. therapy on overall visual functioning as assessed by the Visual Functioning Questionnaire (VFQ)-25 test.
To evaluate the safety of H.E.L.P. therapy by assessing laboratory tests and vital signs.
To evaluate the effects of H.E.L.P. on the integrity of the outer retinal bands as assessed by Optical Coherence Tomography (OCT)
To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA).
To evaluate the effects of H.E.L.P. therapy on the AREDS severity scale as assessed by colour photography.
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.
To evaluate the effects of H.E.L.P. on the drusen volume as assessed by Optical Coherence Tomography (OCT)
To evaluate the safety of H.E.L.P. therapy by assessing adverse events (AEs).
To evaluate the safety of H.E.L.P. therapy by physical examination.

Full Information

First Posted
April 5, 2013
Last Updated
November 22, 2016
Sponsor
B.Braun Avitum AG
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1. Study Identification

Unique Protocol Identification Number
NCT01840683
Brief Title
HELP Therapy for Dry AMD
Acronym
HELPuc
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B.Braun Avitum AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
Other Intervention Name(s)
Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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.
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareed Ali, MD, FRCS(C)
Organizational Affiliation
Canadian Centre for Advanced Eye Therapeutics Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Centre for Advanced Eye Therapeutics Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada

12. IPD Sharing Statement

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HELP Therapy for Dry AMD

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