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| Brief Title † | A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration | ||||||||
| Official Title † | 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 | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Percentage of subjects gaining ≥ 15 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ] Percentage of subjects gaining ≥ 0 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ] Mean change in ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
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| Condition † | Macular Degeneration | ||||||||
| Intervention † | Device: Epi-Rad90™ Ophthalmic System Drug: ranibizumab |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 450 | ||||||||
| Start Date † | April 2007 | ||||||||
| Completion Date | April 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Austria, Germany, Ireland, Israel, Peru, Spain, Switzerland, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00454389 | ||||||||
| Organization ID | NVI-114 | ||||||||
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| Study Sponsor † | NeoVista | ||||||||
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| Information Provided By | NeoVista | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | March 28, 2007 | ||||||||
| Last Updated Date | November 21, 2008 | ||||||||