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

July 26, 2011 updated by: NeoVista

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Augenklinik Graz
  • Germany
      • Leipzig, Germany, 04103
        • Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
      • Würzburg, Germany, 97080
        • Universitätsklinik und polyklinik für Augenkranke
  • Ireland
      • Belfast, Ireland
        • Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
  • Israel
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
  • Peru
      • Lima, Peru
        • Oftalmo Salud Eye Institute
  • Spain
      • Barcelona, Spain
        • Institutio de Microcirugia Ocular-Barcelona
  • Switzerland
      • Geneva, Switzerland, 1211GE14
        • University of Geneva
  • United Kingdom
      • London, United Kingdom
        • Kings College Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Center, PC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • San Francisco, California, United States, 94143
        • UCSF Koret Vision Center
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Retina Group of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Retina Institute of Hawaii
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center-Tufts University
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants / William Beaumont Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Eye Foundation of Kansas City
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye Ear Nose & Throat Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Retina Research Unit of Wills Eye Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78240
        • Retina & Uveitis Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
No loss in ETDRS letters
Time Frame: 12 months
12 months
Change in total lesion size and CNV size by fluorescein angiography
Time Frame: 12 months
12 months
Number of rescue injections of Lucentis.
Time Frame: 12 months
12 months
Mean change in ETDRS visual acuity
Time Frame: 12 months
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoVista

Investigators

  • Principal Investigator: Pravin Dugel, MD, Retinal Consultants of Arizona
  • Study Director: Jeffrey A Nau, MMS, NeoVista, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (Estimate)

March 30, 2007

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVI-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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