Clinical trial NCT01840683: HELP Therapy for Dry AMD
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
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: B.Braun Avitum AG
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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.
timeFrame: Change from Baseline in the best corrected visual acuity (BCVA) at Week 24 after completion of H.E.L.P. therapy
Secondary outcomes:
measure: To evaluate the effects of H.E.L.P. therapy on the change in drusen area as assessed by colour photography.
timeFrame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF).
timeFrame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the effects of H.E.L.P. therapy on overall visual functioning as assessed by the Visual Functioning Questionnaire (VFQ)-25 test.
timeFrame: Change from Baselineto Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the safety of H.E.L.P. therapy by assessing laboratory tests and vital signs.
timeFrame: Baseline and at all HELP therapy sessions being conducted after Baseline within 12 weeks.
measure: To evaluate the effects of H.E.L.P. on the integrity of the outer retinal bands as assessed by Optical Coherence Tomography (OCT)
timeFrame: Change from Baseline in integrity of the outer retinal bands at Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA).
timeFrame: Change from Baseline to Week 52 after completion of H.E.L.P. therapy
measure: To evaluate the effects of H.E.L.P. therapy on the AREDS severity scale as assessed by colour photography.
timeFrame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: 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.
timeFrame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the effects of H.E.L.P. on the drusen volume as assessed by Optical Coherence Tomography (OCT)
timeFrame: Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy
measure: To evaluate the safety of H.E.L.P. therapy by assessing adverse events (AEs).
timeFrame: 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.
measure: To evaluate the safety of H.E.L.P. therapy by physical examination.
timeFrame: 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.
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Canadian Centre for Advanced Eye Therapeutics Inc.
state: Ontario
Study officials:
affiliation: Canadian Centre for Advanced Eye Therapeutics Inc.
name: Fareed Ali, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: