Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454389
Recruitment Status : Unknown
Verified July 2011 by NeoVista.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2007
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
NeoVista

Tracking Information
First Submitted Date  ICMJE March 28, 2007
First Posted Date  ICMJE March 30, 2007
Last Update Posted Date July 27, 2011
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2007)
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • No loss in ETDRS letters [ Time Frame: 12 months ]
  • Change in total lesion size and CNV size by fluorescein angiography [ Time Frame: 12 months ]
  • Number of rescue injections of Lucentis. [ Time Frame: 12 months ]
  • Mean change in ETDRS visual acuity [ Time Frame: 12 months ]
  • Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2007)
  • Percentage of subjects gaining ≥ 15 ETDRS letters
  • Percentage of subjects gaining ≥ 0 ETDRS letters
  • Mean change in ETDRS visual acuity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE
  • Device: Epi-Rad90™ Ophthalmic System
    A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
  • Drug: ranibizumab
    Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
    Other Name: Lucentis
Study Arms  ICMJE
  • Experimental: A
    Epi-Rad90™ Ophthalmic System procedure + Lucentis
    Intervention: Device: Epi-Rad90™ Ophthalmic System
  • Active Comparator: B
    Lucentis only
    Intervention: Drug: ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
494
Original Enrollment  ICMJE
 (submitted: March 29, 2007)
450
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Ireland,   Israel,   Peru,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454389
Other Study ID Numbers  ICMJE NVI-114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc.
Study Sponsor  ICMJE NeoVista
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pravin Dugel, MD Retinal Consultants of Arizona
Study Director: Jeffrey A Nau, MMS NeoVista, Inc.
PRS Account NeoVista
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP