A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
Information source: NeoVista
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: Epi-Rad90™ Ophthalmic System (Device); ranibizumab (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: NeoVista Official(s) and/or principal investigator(s):
Nelson R Sabates, MD, Principal Investigator, Affiliation: Eye Foundation of Kansas City, UMKC
Jeffrey A Nau, MMS, Study Director, Affiliation: NeoVista, Inc.
Overall contact:
Jeffrey A Nau, MMS, Email: clinicaltrials@neovistainc.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline
Secondary outcome: Percentage of subjects gaining ≥ 15 ETDRS lettersPercentage of subjects gaining ≥ 0 ETDRS letters Mean change in ETDRS visual acuity
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jeffrey A Nau, MMS, Email: clinicaltrials@neovistainc.com
Augenklinik Graz, Graz, Austria; Recruiting
Email: clinicaltrials@neovistainc.com
Universitätsklinik und polyklinik für Augenkranke, Würzburg 97080, Germany; Recruiting
Email: clinicaltrials@neovistainc.com
Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR, Leipzig 04103, Germany; Recruiting
Email: clinicaltrials@neovistainc.com
Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital, Belfast, Ireland; Recruiting
Email: clinicaltrials@neovistainc.com
Sourasky Medical Center, Tel Aviv 64239, Israel; Recruiting
Email: clinicaltrials@neovistainc.com
Oftalmo Salud Eye Institute, Lima, Peru; Recruiting
Email: clinicaltrials@neovistainc.com
Institutio de Microcirugia Ocular-Barcelona, Barcelona, Spain; Recruiting
Email: clinicaltrials@neovistainc.com
University of Geneva, Geneva 1211GE14, Switzerland; Recruiting
Email: clinicaltrials@neovistainc.com
Kings College Hospital, London, United Kingdom; Recruiting
Email: clinicaltrials@neovistainc.com
Retinal Consultants of Arizona, Phoenix, Arizona 85014, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Retinal Diagnostic Center, Campbell, California 95008, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Northern California Retina Vitreous Associates, Mountain View, California 94040, United States; Recruiting
Email: clinicaltrials@neovistainc.com
UCSF Koret Vision Center, San Francisco, California 94143, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Retina Group of Florida, Ft. Lauderdale, Florida 33334, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Bascom Palmer Eye Institute, Miami, Florida 33136, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Paducah Retinal Center, Paducah, Kentucky 42001, United States; Recruiting
Email: clinicaltrials@neovistainc.com
New England Eye Center-Tufts University, Boston, Massachusetts 02111, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Associated Retinal Consultants / William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Eye Foundation of Kansas City, Kansas City, Missouri 64108, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Charlotte Eye Ear Nose & Throat Associates, Charlotte, North Carolina 28210, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Retina Research Unit of Wills Eye Hospital, Philadelphia, Pennsylvania 19107, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Vanderbilt University, Nashville, Tennessee 37232, United States; Withdrawn
Retina Vitreous Associates, Nashville, Tennessee 37203, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Retina Research Center, Austin, Texas 78705, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Retina & Uveitis Consultants of Texas, San Antonio, Texas 78240, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Medical Center Ophthalmology Associates, San Antonio, Texas 78240, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Vitreoretinal Consultants, Houston, Texas 77030, United States; Recruiting
Email: clinicaltrials@neovistainc.com
University of Wisconsin, Madison, Wisconsin 53705, United States; Recruiting
Email: clinicaltrials@neovistainc.com
Additional Information
Starting date: April 2007
Ending date: April 2011
Last updated: July 24, 2008
|
