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OpenTrials
Completed

NCT Number: NCT01840683

HELP Therapy for Dry 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.

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Key information

Conditions

Non-exudative (Dry) Age-related Macular Degeneration (AMD) Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Centre for Advanced Eye Therapeutics Inc.

Mississauga, Ontario, L4W 1W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Other names: Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

B.Braun Avitum AG

Industry

Registry information

Official study 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)

Acronym: HELPuc

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2013
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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