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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. 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
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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
Macular Degeneration Device: Epi-Rad90™ Ophthalmic System Drug: ranibizumab 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2007
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: Lucentis

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 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. No loss in ETDRS letters [ Time Frame: 12 months ]
  2. Change in total lesion size and CNV size by fluorescein angiography [ Time Frame: 12 months ]
  3. Number of rescue injections of Lucentis. [ Time Frame: 12 months ]
  4. Mean change in ETDRS visual acuity [ Time Frame: 12 months ]
  5. Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454389

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

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Responsible Party: NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc. Identifier: NCT00454389    
Other Study ID Numbers: NVI-114
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2011
Keywords provided by NeoVista:
Wet Age-Related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents