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

Status unconfirmed · Phase 3

Conditions studied: Macular Degeneration

In brief

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 facts

Study ID

NCT00454389

Run by

NeoVista

People needed

494

Starts

2007-04-01

Expected to finish

2012-08-01

Last updated by the study team

2011-07-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, United States
• Retina Center, PC — Tucson, Arizona, United States
• Retina-Vitreous Associates Medical — Beverly Hills, California, United States
• Retinal Diagnostic Center — Campbell, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• UCSF Koret Vision Center — San Francisco, California, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Retina Institute of Hawaii — Honolulu, Hawaii, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• New England Eye Center-Tufts University — Boston, Massachusetts, United States
• Associated Retinal Consultants / William Beaumont Hospital — Royal Oak, Michigan, United States
• Eye Foundation of Kansas City — Kansas City, Missouri, United States
• Charlotte Eye Ear Nose & Throat Associates — Charlotte, North Carolina, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Retina Research Unit of Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• Tennessee Retina — Nashville, Tennessee, United States
• Austin Retina Associates — Austin, Texas, United States
• Retina Research Center — Austin, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retina & Uveitis Consultants of Texas — San Antonio, Texas, United States
• Rocky Mountain Retina Consultants — Salt Lake City, Utah, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Augenklinik Graz — Graz, Austria
• Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR — Leipzig, Germany

Full record on ClinicalTrials.gov

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