NCT01339949

Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)

A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oraya Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Detailed description

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Conditions

• Wet Age-related Macular Degeneration
• Age-related Macular Degeneration
• AMD
• Wet AMD
• Macular Degeneration

Interventions

Type	Name	Description
DEVICE	IRay	low voltage external beam radiosurgery
DEVICE	IRay	low voltage external beam radiosurgery

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-10-01
• Completion: 2014-10-01
• First posted: 2011-04-21
• Last updated: 2011-12-30

Locations

3 sites across 2 countries: Italy, United Kingdom