Status:
UNKNOWN
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
Lead Sponsor:
NeoVista
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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-rela...
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 tri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00454389
Start Date
April 1 2007
End Date
August 1 2012
Last Update
July 27 2011
Active Locations (32)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
Retina Center, PC
Tucson, Arizona, United States, 85704
3
Retina-Vitreous Associates Medical
Beverly Hills, California, United States, 90211
4
Retinal Diagnostic Center
Campbell, California, United States, 95008