Radioactive surgery aims for selective radiation delivery to CNV membranes

February 21, 2006

Encouraging results have been achieved in a pilot clinical trial of selective epiretinal brachytherapy for exudative age-related macular degeneration (AMD), reported Eugene de Juan, Jr., MD, at the World Ophthalmology Congress.

Encouraging results have been achieved in a pilot clinical trial of selective epiretinal brachytherapy for exudative age-related macular degeneration (AMD), reported Eugene de Juan, Jr., MD, at the World Ophthalmology Congress.

By delivering beta radiation directly over the choroidal neovascular lesion in a controlled way with an intraocular probe, selective epiretinal brachytherapy is designed to provide efficient "radioactive surgery" with the benefits of high-dose external beam radiation therapy while avoiding or minimizing the latter's adverse effects on vision loss.

The pilot study, which is still ongoing, is being conducted at sites in Brazil, Mexico, and Turkey, and was designed to collect preliminary safety and feasibility data, refine the surgical technique, and investigate dosing.

From a surgical perspective, the procedure was associated with favorable safety. There were no retinal detachments, no infections, no retinal pigment epithelium rips, and only occasional postoperative hemorrhages that were mild and not visually important. Efficacy was also promising in the pilot trial. No patients experienced moderate or severe vision loss, while the majority of patients showed vision gains. At 3 months, vision was improved in 54% of 24 evaluated patients, with a mean gain of 7.3 letters. There were 13 patients who reached the 6-month visit, and among them, 62% benefited with improved vision. The mean gain in that analysis was 6.5 letters.

"We have now received IDE approval from the FDA and a multicenter trial is planned to begin in 2006. Hopefully, further studies will find that epiretinal brachytherapy might be a good adjunctive or sole therapy for exudative AMD," said Dr. DeJuan of the University of Southern California in the United States.