A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
CABERNET
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
1 other identifier
interventional
494
9 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJuly 27, 2011
July 1, 2011
4.4 years
March 28, 2007
July 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (5)
No loss in ETDRS letters
12 months
Change in total lesion size and CNV size by fluorescein angiography
12 months
Number of rescue injections of Lucentis.
12 months
Mean change in ETDRS visual acuity
12 months
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
3 years
Study Arms (2)
A
EXPERIMENTALEpi-Rad90™ Ophthalmic System procedure + Lucentis
B
ACTIVE COMPARATORLucentis only
Interventions
A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoVistalead
Study Sites (32)
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina Center, PC
Tucson, Arizona, 85704, United States
Retina-Vitreous Associates Medical
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
UCSF Koret Vision Center
San Francisco, California, 94143, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33334, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Retina Institute of Hawaii
Honolulu, Hawaii, 96814, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
New England Eye Center-Tufts University
Boston, Massachusetts, 02111, United States
Associated Retinal Consultants / William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Eye Foundation of Kansas City
Kansas City, Missouri, 64108, United States
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, 28210, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Retina Research Unit of Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Tennessee Retina
Nashville, Tennessee, 37203, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center
Austin, Texas, 78705, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina & Uveitis Consultants of Texas
San Antonio, Texas, 78240, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Augenklinik Graz
Graz, Austria
Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
Leipzig, 04103, Germany
Universitätsklinik und polyklinik für Augenkranke
Würzburg, 97080, Germany
Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
Belfast, Ireland
Sourasky Medical Center
Tel Aviv, 64239, Israel
Oftalmo Salud Eye Institute
Lima, Peru
Institutio de Microcirugia Ocular-Barcelona
Barcelona, Spain
University of Geneva
Geneva, 1211GE14, Switzerland
Kings College Hospital
London, United Kingdom
Related Publications (1)
Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4.
PMID: 32844399DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pravin Dugel, MD
Retinal Consultants of Arizona
- STUDY DIRECTOR
Jeffrey A Nau, MMS
NeoVista, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 30, 2007
Study Start
April 1, 2007
Primary Completion
September 1, 2011
Study Completion
August 1, 2012
Last Updated
July 27, 2011
Record last verified: 2011-07