NCT00940407

Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration

A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Merry, Graham, M.D. · Individual
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD). Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression. This is a prospective 2 center phase 2 clinical pilot study with no placebo group.

Detailed description

Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss. There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD cases. There are estimated to be 30 million people afflicted with AMD by the year 2020 in North America. Photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the FDA and Health Canada. Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot study there is no placebo or control group.

Conditions

• Nonexudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Photobiomodulation (Gentlewaves, Warp 10)	Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-07-16
• Last updated: 2011-11-18

Locations

2 sites across 2 countries: United States, Canada