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A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration (CABERNET)
This study is currently recruiting participants.
Study NCT00454389.   Last updated on November 21, 2008.
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A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
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.

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of subjects gaining ≥ 15 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of subjects gaining ≥ 0 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change in ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Macular Degeneration
Device: Epi-Rad90™ Ophthalmic System
Drug: ranibizumab
 
Recruiting
450
April 2007
April 2011

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
Both
50 Years and older
No
Contact: Jeffrey A Nau, MMS clinicaltrials@neovistainc.com
United States,   Austria,   Germany,   Ireland,   Israel,   Peru,   Spain,   Switzerland,   United Kingdom
 
NCT00454389
NVI-114
NeoVista
Principal Investigator: Nelson R Sabates, MD Eye Foundation of Kansas City, UMKC
Study Director: Jeffrey A Nau, MMS NeoVista, Inc.
NeoVista
November 2008
March 28, 2007
November 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.