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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Canadian Centre for Advanced Eye Therapeutics Inc.
Mississauga, Ontario, Canada
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
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.
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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.