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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
NeoVista
Study ID
NCT00454389
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epi-Rad90™ Ophthalmic System — DEVICE
    A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
  • ranibizumab — DRUG
    Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

Study Details

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.

Key Dates

First listed
Mar 30, 2007
Start date
Apr 30, 2007
Status verified
Jul 2011
Primary completion
Sep 30, 2011
Completion
Aug 31, 2012

Study Design

Enrollment
494 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Epi-Rad90™ Ophthalmic System procedure + Lucentis
  • Active Comparator: B
    Lucentis only

Primary Outcome Measure

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 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Retinal Consultants of ArizonaPhoenixArizona85014-
Retina Center, PCTucsonArizona85704-
Retina-Vitreous Associates MedicalBeverly HillsCalifornia90211-
Retinal Diagnostic CenterCampbellCalifornia95008-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-
UCSF Koret Vision CenterSan FranciscoCalifornia94143-
Retina Group of FloridaFort LauderdaleFlorida33334-
Southeast Retina CenterAugustaGeorgia30909-
Retina Institute of HawaiiHonoluluHawaii96814-
Paducah Retinal CenterPaducahKentucky42001-
New England Eye Center-Tufts UniversityBostonMassachusetts02111-
Associated Retinal Consultants / William Beaumont HospitalRoyal OakMichigan48073-
Eye Foundation of Kansas CityKansas CityMissouri64108-
Charlotte Eye Ear Nose & Throat AssociatesCharlotteNorth Carolina28210-
Cincinnati Eye InstituteCincinnatiOhio45242-
Retina Research Unit of Wills Eye HospitalPhiladelphiaPennsylvania19107-
Tennessee RetinaNashvilleTennessee37203-
Austin Retina AssociatesAustinTexas78705-
Retina Research CenterAustinTexas78705-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retina & Uveitis Consultants of TexasSan AntonioTexas78240-
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retinal Consultants of Arizona· Phoenix, AZRetina Center, PC· Tucson, AZRetina-Vitreous Associates Medical· Beverly Hills, CARetinal Diagnostic Center· Campbell, CANorthern California Retina Vitreous Associates· Mountain View, CAUCSF Koret Vision Center· San Francisco, CA

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