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CABERNET: A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration

Sponsor
NeoVista (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00454389
Collaborator
(none)
494
Enrollment
32
Locations
2
Arms
64
Duration (Months)
15.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
494 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2007
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. No loss in ETDRS letters [12 months]

    2. Change in total lesion size and CNV size by fluorescein angiography [12 months]

    3. Number of rescue injections of Lucentis. [12 months]

    4. Mean change in ETDRS visual acuity [12 months]

    5. Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Phoenix Arizona United States 85014
    2 Retina Center, PC Tucson Arizona United States 85704
    3 Retina-Vitreous Associates Medical Beverly Hills California United States 90211
    4 Retinal Diagnostic Center Campbell California United States 95008
    5 Northern California Retina Vitreous Associates Mountain View California United States 94040
    6 UCSF Koret Vision Center San Francisco California United States 94143
    7 Retina Group of Florida Ft. Lauderdale Florida United States 33334
    8 Southeast Retina Center Augusta Georgia United States 30909
    9 Retina Institute of Hawaii Honolulu Hawaii United States 96814
    10 Paducah Retinal Center Paducah Kentucky United States 42001
    11 New England Eye Center-Tufts University Boston Massachusetts United States 02111
    12 Associated Retinal Consultants / William Beaumont Hospital Royal Oak Michigan United States 48073
    13 Eye Foundation of Kansas City Kansas City Missouri United States 64108
    14 Charlotte Eye Ear Nose & Throat Associates Charlotte North Carolina United States 28210
    15 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    16 Retina Research Unit of Wills Eye Hospital Philadelphia Pennsylvania United States 19107
    17 Tennessee Retina Nashville Tennessee United States 37203
    18 Austin Retina Associates Austin Texas United States 78705
    19 Retina Research Center Austin Texas United States 78705
    20 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
    21 Retina & Uveitis Consultants of Texas San Antonio Texas United States 78240
    22 Rocky Mountain Retina Consultants Salt Lake City Utah United States 84107
    23 University of Wisconsin Madison Wisconsin United States 53705
    24 Augenklinik Graz Graz Austria
    25 Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR Leipzig Germany 04103
    26 Universitätsklinik und polyklinik für Augenkranke Würzburg Germany 97080
    27 Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital Belfast Ireland
    28 Sourasky Medical Center Tel Aviv Israel 64239
    29 Oftalmo Salud Eye Institute Lima Peru
    30 Institutio de Microcirugia Ocular-Barcelona Barcelona Spain
    31 University of Geneva Geneva Switzerland 1211GE14
    32 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00454389
    Other Study ID Numbers:
    • NVI-114
    First Posted:
    Mar 30, 2007
    Last Update Posted:
    Jul 27, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Macular
    Degeneration
    AMD
    Wet Age-Related macular degeneration
    Additional relevant MeSH terms:
    Macular Degeneration
    Ranibizumab

    Study Results

    No Results Posted as of Jul 27, 2011