Trials / Unknown
UnknownNCT00454389
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 494 (actual)
- Sponsor
- NeoVista · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
Detailed description
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Epi-Rad90™ Ophthalmic System | A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart |
| DRUG | ranibizumab | Lucentis injection administered monthly for the first 3 injections followed by quarterly injections |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-09-01
- Completion
- 2012-08-01
- First posted
- 2007-03-30
- Last updated
- 2011-07-27
Locations
32 sites across 9 countries: United States, Austria, Germany, Ireland, Israel, Peru, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00454389. Inclusion in this directory is not an endorsement.