A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration - Full Text View

Sponsor:	NeoVista
Information provided by:	NeoVista
ClinicalTrials.gov Identifier:	NCT00454389

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: 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 [ 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 ]
Mean change in ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Active Comparator Lucentis only	Drug: ranibizumab Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

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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Locations

United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
Retina Center, PC
Tucson, Arizona, United States, 85704
United States, California
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
Retina-Vitreous Associates Medical
Beverly Hills, California, United States, 90211
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
Retina & Uveitis Consultants of Texas
San Antonio, Texas, United States, 78240
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Austin Retina Associates
Austin, Texas, United States, 78705
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
Universitätsklinik und polyklinik für Augenkranke
Würzburg, Germany, 97080
Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
Leipzig, Germany, 04103
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. ( NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs )
Study ID Numbers:	NVI-114
Study First Received:	March 28, 2007
Last Updated:	October 28, 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

Keywords provided by NeoVista:

Macular
Degeneration
AMD
Wet Age-Related macular degeneration

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on November 25, 2009