| CABERNET Radiation Implant - Recruiting |
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What this trial is about: CABERNET is a multicenter, randomized, controlled Phase III study that will enroll 450 subjects at 45 clinical centers worldwide. In this research, patients will receive either the standard injection of Lucentis® (ranibizumab) or the radiation plus Lucentis®. A tiny source of radiation is placed inside the eye near the macula, held there for about 4 minutes and then removed. The radiation destroys the abnormal blood vessels and prevents the growth of blood vessels to stop the progression of wet macular degeneration vision loss. Current treatments for wet macular degeneration often require repeated injections in the eye monthly or less often. If epiretinal brachytherapy proves successful, it can reduce the number of injections needed to just two injections over a period of 12 months. For further information on trial sites and eligibility criteria, go to their web site. What happened before: In a previous study, 34 people with wet macular degeneration received a single treatment of NeoVista’s “epiretinal brachytherapy” (these words just mean “close above the retina”). Patients received the radiation and two injections of Avastin® - one dose just before the radiation or at the time of radiation delivery and an additional injection of Avastin® one month later, depending on which group they were in. The patients could receive additional injections of Avastin if the doctor felt it was needed. 76 percent of the patients in the study did not require additional injections of Avastin® throughout the year. After 12 months, 94 percent of patients lost fewer than 15 letters, 39 percent gained 15 or more letters, and 12 percent gained 30 or more letters. (There are 5 letters per line on the vision test; a gain of 15 letters would mean a gain of three lines. For instance, that could mean going from 20/100 vision to 20/40 vision.) Complications included those doctors would expect with this kind of eye surgery but no problems related to the radiation have been reported to date. In contrast to other forms of radiation therapy for wet AMD, NeoVista’s approach targets the peak dose of energy directly to the lesion without damaging the normal blood vessels or other structures within the eye such as the lens and the optic nerve. As you get further away from the radiation source, the level of radiation drops so that radiation exposure to the rest of the patient’s body is less than a typical chest x-ray. |