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)
NCT01339949 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2011-12-30
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.
Conditions
- Wet Age-related Macular Degeneration
- Age-related Macular Degeneration
- AMD
- Wet AMD
- Macular Degeneration
Interventions
- DEVICE
-
IRay
low voltage external beam radiosurgery
- DEVICE
-
IRay
low voltage external beam radiosurgery
Sponsors & Collaborators
-
Oraya Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2012-10-31
- Completion
- 2014-10-31
Countries
- Italy
- United Kingdom
Study Locations
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