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Sponsored by: |
NeoVista |
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Information provided by: | NeoVista |
ClinicalTrials.gov Identifier: | NCT00454389 |
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.
Condition | Intervention | Phase |
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Macular Degeneration |
Device: Epi-Rad90™ Ophthalmic System Drug: ranibizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 450 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Epi-Rad90™ Ophthalmic System procedure + Lucentis
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Device: Epi-Rad90™ Ophthalmic System
A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
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B: Active Comparator
Lucentis only
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Drug: ranibizumab
Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey A Nau, MMS | clinicaltrials@neovistainc.com |
Principal Investigator: | Pravin Dugel, MD | Retinal Consultants of Arizona |
Study Director: | Jeffrey A Nau, MMS | NeoVista, Inc. |
Responsible Party: | NeoVista, Inc. ( NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs ) |
Study ID Numbers: | NVI-114 |
Study First Received: | March 28, 2007 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00454389 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: National Health Surveillance Agency; Spain: Ministry of Health and Consumption; Israel: Ministry of Health; Peru: Ministry of Health |
Macular Degeneration AMD Wet Age-Related macular degeneration |
Uveal Diseases Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration |
Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
Uveal Diseases Pathologic Processes Metaplasia Eye Diseases Choroid Diseases |
Retinal Degeneration Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |