Back to resultsA Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration (CABERNET)
Primary Purpose
Macular Degeneration
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epi-Rad90™ Ophthalmic System
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Macular, Degeneration, AMD, Wet Age-Related macular degeneration
Eligibility 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
Sites / Locations
- Retinal Consultants of Arizona
- Retina Center, PC
- Retina-Vitreous Associates Medical
- Retinal Diagnostic Center
- Northern California Retina Vitreous Associates
- UCSF Koret Vision Center
- Retina Group of Florida
- Southeast Retina Center
- Retina Institute of Hawaii
- Paducah Retinal Center
- New England Eye Center-Tufts University
- Associated Retinal Consultants / William Beaumont Hospital
- Eye Foundation of Kansas City
- Charlotte Eye Ear Nose & Throat Associates
- Cincinnati Eye Institute
- Retina Research Unit of Wills Eye Hospital
- Tennessee Retina
- Austin Retina Associates
- Retina Research Center
- Medical Center Ophthalmology Associates
- Retina & Uveitis Consultants of Texas
- Rocky Mountain Retina Consultants
- University of Wisconsin
- Augenklinik Graz
- Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
- Universitätsklinik und polyklinik für Augenkranke
- Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
- Sourasky Medical Center
- Oftalmo Salud Eye Institute
- Institutio de Microcirugia Ocular-Barcelona
- University of Geneva
- Kings College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Epi-Rad90™ Ophthalmic System procedure + Lucentis
Lucentis only
Outcomes
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
Secondary Outcome Measures
No loss in ETDRS letters
Change in total lesion size and CNV size by fluorescein angiography
Number of rescue injections of Lucentis.
Mean change in ETDRS visual acuity
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00454389
Brief Title
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
Acronym
CABERNET
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
NeoVista
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Macular, Degeneration, AMD, Wet Age-Related macular degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Epi-Rad90™ Ophthalmic System procedure + Lucentis
Arm Title
B
Arm Type
Active Comparator
Arm Description
Lucentis only
Intervention Type
Device
Intervention Name(s)
Epi-Rad90™ Ophthalmic System
Intervention Description
A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
No loss in ETDRS letters
Time Frame
12 months
Title
Change in total lesion size and CNV size by fluorescein angiography
Time Frame
12 months
Title
Number of rescue injections of Lucentis.
Time Frame
12 months
Title
Mean change in ETDRS visual acuity
Time Frame
12 months
Title
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pravin Dugel, MD
Organizational Affiliation
Retinal Consultants of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey A Nau, MMS
Organizational Affiliation
NeoVista, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Center, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina-Vitreous Associates Medical
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
UCSF Koret Vision Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Retina Group of Florida
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Institute of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
New England Eye Center-Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Associated Retinal Consultants / William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Eye Foundation of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Research Unit of Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Tennessee Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina & Uveitis Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Rocky Mountain Retina Consultants
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Augenklinik Graz
City
Graz
Country
Austria
Facility Name
Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinik und polyklinik für Augenkranke
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
City
Belfast
Country
Ireland
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Oftalmo Salud Eye Institute
City
Lima
Country
Peru
Facility Name
Institutio de Microcirugia Ocular-Barcelona
City
Barcelona
Country
Spain
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1211GE14
Country
Switzerland
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32844399
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
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