Trials / Completed
CompletedNCT01016873
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
A Double-masked, Sham Controlled, Dose-ranging Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- Oraya Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the safety and establish the effectiveness of two doses from the IRay System for the treatment of wet AMD.
Detailed description
The purpose of this study is to confirm the safety of low voltage external beam radiotherapy using the IRay System at two dose levels for the treatment of CNV secondary to neovascular AMD and to determine if the IRay System is effective in sparing the number of Lucentis injections during the first 12 months.
Conditions
- AMD
- Wet AMD
- Age-Related Macular Degeneration
- Wet Age-Related Macular Degeneration
- Macular Degeneration
- Eye Diseases
- Retinal Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IRay | Low voltage stereotactic radiotherapy system |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2012-05-01
- Completion
- 2014-04-01
- First posted
- 2009-11-20
- Last updated
- 2014-12-05
- Results posted
- 2014-12-05
Locations
21 sites across 5 countries: Austria, Czechia, Germany, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT01016873. Inclusion in this directory is not an endorsement.