Study begins for Radiation Therapy for Wet AMD
This unique clinical trial which hasn’t been seen anywhere before is to be conducted by Oraya Therapeutics enrolling at least 150 patients from seven different European countries. The trial involves what they call a masked and sham-controlled test to review any risks or benefits through the treatment of “Wet” Age-related Macular Degeneration by radiation therapy.
The company have released their proposals in a press release stating that around two-thirds of the test group will receive radiation at dosages 16 or 24 Gray (GY) with the remaining third receiving sham exposure. However, all patients will be undergoing standard care afterwards involving anti-VEGF injections. The test results should then reveal the effects radiation has on both the frequency of these anti-VEGF injections and visual improvements. The treatment lasts around 15-20 minutes and can be carried out using a topical anesthetic. Using the company’s IRay system the patient’s eye is subjected to low-dose X-rays and is used alongside the company’s I-Guide™ (a vacuum-coupled contact lens). The I-Guide detects any movement, if the patient moves perhaps, and shuts a guard down automatically to prevent the radiation from being misaligned.
With the data from a study conducted previously which also includes a year of follow-up the potential positive outcome of this latest trial is evident. Professor Darius Moshfeghi of Stanford University comments that the safety of the test is “excellent” so far and he is excited to see how the treatment could excel in this well designed new trial by Oraya. The hope is that the treatment will benefit costs, patient outcome and the treatment worry. Equally, as the treatment uses X-rays which are of a much lower voltage than that of chest X-rays and so on, the treatment can in fact be carried out within an ophthalmology office.
8th January 2010
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