HELP Therapy for Dry AMD

NCT01840683 | Completed

• 1 other identifier: BA-I-H-1202
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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).

  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

Study Arms (1)

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.

Device: H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)

Interventions

H.E.L.P. therapy (H.E.L.P. Plasmat Futura System) DEVICE

Also known as: Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation

H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• B.Braun Avitum AG: lead

Study Sites (1)

Canadian Centre for Advanced Eye Therapeutics Inc.

Mississauga, Ontario, L4W 1W9, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Fareed Ali, MD, FRCS(C)

  Canadian Centre for Advanced Eye Therapeutics Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

CA (1)