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HELP Therapy for Dry AMD

NCT01840683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-11-23

No results posted yet for this study

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)

Interventions

DEVICE

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

Sponsors & Collaborators

  • B.Braun Avitum AG

    lead INDUSTRY

Principal Investigators

  • Fareed Ali, MD, FRCS(C) · Canadian Centre for Advanced Eye Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840683 on ClinicalTrials.gov