Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| To evaluate the effects of H.E.L.P. therapy in area of abnormal autofluorescence as assessed by Fundus Autofluorescence (FAF). |
Not provided
Inclusion Criteria:
Exclusion Criteria (related to the underlying disease):
Exclusion Criteria (General):
Exclusion Criteria (H.E.L.P. Apheresis):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fareed Ali, MD, FRCS(C) | Canadian Centre for Advanced Eye Therapeutics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Centre for Advanced Eye Therapeutics Inc. | Mississauga | Ontario | L4W 1W9 | Canada |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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) | 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). | 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. | 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. | 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) | 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). | 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. | 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. |