NCT01840683

HELP Therapy for Dry AMD

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: B.Braun Avitum AG · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2013-04-26
• Last updated: 2016-11-23

Locations

1 site across 1 country: Canada