Non-exudative (Dry) Age-related Macular Degeneration (AMD)HELPucNCT01840683
HELP Therapy for Dry AMD
A study testing H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) in people with Non-exudative (Dry) Age-related Macular Degeneration (AMD), run by B.Braun Avitum AG at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Non-exudative (Dry) Age-related Macular Degeneration (AMD)
- What is being tested?
- H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Centre for Advanced Eye Therapeutics Inc.
Mississauga, Ontario, L4W 1W9
About this study
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)
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.
- Being tested
- H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
- 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)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)Device
Also called Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation
| Study group | Role | What they receive |
|---|---|---|
| H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) | Experimental | A total of 8 apheresis therapies with the H.E.L.P. Plasmat Futura System will be performed over a period of 12 weeks. Receives: Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA) in patients with non-exudative (dry) AMD.
Measured: Change from Baseline in the best corrected visual acuity (BCVA) at Week 24 after completion of H.E.L.P. therapy
Secondary outcomes (11)
To evaluate the effects of H.E.L.P. therapy on the change in drusen area as assessed by colour photography.
Measured: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF).
Measured: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the effects of H.E.L.P. therapy on overall visual functioning as assessed by the Visual Functioning Questionnaire (VFQ)-25 test.
Measured: Change from Baselineto Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the safety of H.E.L.P. therapy by assessing laboratory tests and vital signs.
Measured: Baseline and at all HELP therapy sessions being conducted after Baseline within 12 weeks.
To evaluate the effects of H.E.L.P. on the integrity of the outer retinal bands as assessed by Optical Coherence Tomography (OCT)
Measured: Change from Baseline in integrity of the outer retinal bands at Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA).
Measured: Change from Baseline to Week 52 after completion of H.E.L.P. therapy
To evaluate the effects of H.E.L.P. therapy on the AREDS severity scale as assessed by colour photography.
Measured: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
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.
Measured: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the effects of H.E.L.P. on the drusen volume as assessed by Optical Coherence Tomography (OCT)
Measured: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
To evaluate the safety of H.E.L.P. therapy by assessing adverse events (AEs).
Measured: 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.
To evaluate the safety of H.E.L.P. therapy by physical examination.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-exudative (Dry) Age-related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.Braun Avitum AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fareed Ali, MD, FRCS(C), Principal investigator, Canadian Centre for Advanced Eye Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840683
- Sponsor's protocol ID
- BA-I-H-1202
- Acronym
- HELPuc
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2013
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01840683
- Acronym / sponsor ID
- HELPuc / BA-I-H-1202
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- B.Braun Avitum AGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) | Experimental | Device: 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)Also: Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation | Device | H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) |
Primary outcome
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
11 secondary outcomes
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
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
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
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.
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
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
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fareed Ali, MD, FRCS(C) principal investigator
Canadian Centre for Advanced Eye Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) in people with Non-exudative (Dry) Age-related Macular Degeneration (AMD), run by B.Braun Avitum AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.