Non-exudative (Dry) Age-related Macular Degeneration (AMD) Clinical Trial
— HELPucOfficial 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)
| Verified date | November 2016 |
| Source | B.Braun Avitum AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | November 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 90 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Canadian Centre for Advanced Eye Therapeutics Inc. | Mississauga | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| B.Braun Avitum AG |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA) in patients with non-exudative (dry) AMD. | Change from Baseline in the best corrected visual acuity (BCVA) at Week 24 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. therapy on the change in drusen area as assessed by colour photography. | Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF). | Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. therapy on overall visual functioning as assessed by the Visual Functioning Questionnaire (VFQ)-25 test. | Change from Baselineto Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the safety of H.E.L.P. therapy by assessing laboratory tests and vital signs. | Baseline and at all HELP therapy sessions being conducted after Baseline within 12 weeks. | Yes | |
| Secondary | To evaluate the effects of H.E.L.P. on the integrity of the outer retinal bands as assessed by Optical Coherence Tomography (OCT) | Change from Baseline in integrity of the outer retinal bands at Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. therapy on the best corrected visual acuity (BCVA). | Change from Baseline to Week 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. therapy on the AREDS severity scale as assessed by colour photography. | Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | 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. | Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the effects of H.E.L.P. on the drusen volume as assessed by Optical Coherence Tomography (OCT) | Change from Baseline to Weeks 24 and 52 after completion of H.E.L.P. therapy | No | |
| Secondary | To evaluate the safety of H.E.L.P. therapy by assessing adverse events (AEs). | 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. | Yes | |
| Secondary | To evaluate the safety of H.E.L.P. therapy by physical examination. | 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. | Yes |