Overview

This trial has been completed.

Condition non-exudative (dry) age-related macular degeneration (amd)
Treatment h.e.l.p. therapy (h.e.l.p. plasmat futura system)
Sponsor B.Braun Avitum AG
Start date May 2013
End date September 2016
Trial size 22 participants
Trial identifier NCT01840683, BA-I-H-1202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
h.e.l.p. therapy (h.e.l.p. plasmat futura system) Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation

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.
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

Measure
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.
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.

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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

Additional Information

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)
Principal investigator Fareed Ali, MD, FRCS(C)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by B.Braun Avitum AG.