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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by NeoVista.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NeoVista
ClinicalTrials.gov Identifier:
NCT00454389
First received: March 28, 2007
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Macular Degeneration
Device: Epi-Rad90™ Ophthalmic System
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NeoVista:

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Enrollment: 494
Study Start Date: April 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454389

  Show 32 Study Locations
Sponsors and Collaborators
NeoVista
Investigators
Principal Investigator: Pravin Dugel, MD Retinal Consultants of Arizona
Study Director: Jeffrey A Nau, MMS NeoVista, Inc.
  More Information

No publications provided

Responsible Party: NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc.
ClinicalTrials.gov Identifier: NCT00454389     History of Changes
Other Study ID Numbers: NVI-114
Study First Received: March 28, 2007
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
Spain: Ministry of Health and Consumption
Israel: Ministry of Health
Peru: Ministry of Health

Keywords provided by NeoVista:
Macular
Degeneration
AMD
Wet Age-Related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014