A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration (CABERNET)
This study is ongoing, but not recruiting participants.
Sponsor:
NeoVista
Information provided by:
NeoVista
ClinicalTrials.gov Identifier:
NCT00454389
First received: March 28, 2007
Last updated: July 26, 2011
Last verified: July 2011
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Purpose
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 |
|---|---|---|
|
Macular Degeneration |
Device: Epi-Rad90™ Ophthalmic System Drug: ranibizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Ranibizumab
U.S. FDA Resources
Further study details as provided by NeoVista:
Primary Outcome Measures:
- Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- No loss in ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in total lesion size and CNV size by fluorescein angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of rescue injections of Lucentis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean change in ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 494 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Epi-Rad90™ Ophthalmic System procedure + Lucentis
|
Device: Epi-Rad90™ Ophthalmic System
A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
|
|
Active Comparator: B
Lucentis only
|
Drug: ranibizumab
Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
Other Name: Lucentis
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
- Subjects must be age 50 or older
Exclusion Criteria:
- Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
- Subjects who underwent previous radiation therapy to the eye, head or neck
- Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454389
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Hide Study LocationsLocations
| United States, Arizona | |
| Retinal Consultants of Arizona | |
| Phoenix, Arizona, United States, 85014 | |
| Retina Center, PC | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Retina-Vitreous Associates Medical | |
| Beverly Hills, California, United States, 90211 | |
| Retinal Diagnostic Center | |
| Campbell, California, United States, 95008 | |
| Northern California Retina Vitreous Associates | |
| Mountain View, California, United States, 94040 | |
| UCSF Koret Vision Center | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Retina Group of Florida | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| United States, Georgia | |
| Southeast Retina Center | |
| Augusta, Georgia, United States, 30909 | |
| United States, Hawaii | |
| Retina Institute of Hawaii | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Kentucky | |
| Paducah Retinal Center | |
| Paducah, Kentucky, United States, 42001 | |
| United States, Massachusetts | |
| New England Eye Center-Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Associated Retinal Consultants / William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Missouri | |
| Eye Foundation of Kansas City | |
| Kansas City, Missouri, United States, 64108 | |
| United States, North Carolina | |
| Charlotte Eye Ear Nose & Throat Associates | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Ohio | |
| Cincinnati Eye Institute | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Pennsylvania | |
| Retina Research Unit of Wills Eye Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Tennessee Retina | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Retina Research Center | |
| Austin, Texas, United States, 78705 | |
| Austin Retina Associates | |
| Austin, Texas, United States, 78705 | |
| Retina & Uveitis Consultants of Texas | |
| San Antonio, Texas, United States, 78240 | |
| Medical Center Ophthalmology Associates | |
| San Antonio, Texas, United States, 78240 | |
| United States, Utah | |
| Rocky Mountain Retina Consultants | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| Austria | |
| Augenklinik Graz | |
| Graz, Austria | |
| Germany | |
| Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR | |
| Leipzig, Germany, 04103 | |
| Universitätsklinik und polyklinik für Augenkranke | |
| Würzburg, Germany, 97080 | |
| Ireland | |
| Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital | |
| Belfast, Ireland | |
| Israel | |
| Sourasky Medical Center | |
| Tel Aviv, Israel, 64239 | |
| Peru | |
| Oftalmo Salud Eye Institute | |
| Lima, Peru | |
| Spain | |
| Institutio de Microcirugia Ocular-Barcelona | |
| Barcelona, Spain | |
| Switzerland | |
| University of Geneva | |
| Geneva, Switzerland, 1211GE14 | |
| United Kingdom | |
| Kings College Hospital | |
| London, United Kingdom | |
Sponsors and Collaborators
NeoVista
Investigators
| Principal Investigator: | Pravin Dugel, MD | Retinal Consultants of Arizona |
| Study Director: | Jeffrey A Nau, MMS | NeoVista, Inc. |
More Information
No publications provided
| Responsible Party: | NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc. |
| ClinicalTrials.gov Identifier: | NCT00454389 History of Changes |
| Other Study ID Numbers: | NVI-114 |
| Study First Received: | March 28, 2007 |
| Last Updated: | July 26, 2011 |
| 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 |
Keywords provided by NeoVista:
|
Macular Degeneration AMD Wet Age-Related macular degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases |
Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013