NCT01863199

Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD)

A Clinical Trial to Assess the Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Macular Degeneration (the LIBERTY Study).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Retinal Consultants of Arizona · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A study to use in home technology to reduce the burden of in office visits and injections.

Detailed description

Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.

Conditions

• Neovascular Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Lucentis (Treat and extend)	Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
DRUG	Lucentis every 4 weeks	Lucentis 0.5mg administered intravitreally every four weeks for 12 months
DRUG	Lucentis every 12 weeks	Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2013-05-27
• Last updated: 2017-10-04

Locations

4 sites across 1 country: United States