This article is more than 5 years old. Information may no longer be current.
Nonpenetrating brachytherapy device shows positive early safety, efficacy results
Click Here to Manage Email Alerts
SEATTLE — A new brachytherapy approach has been shown to increase best corrected visual acuity and was well-tolerated in a small group of patients with age-related macular degeneration, according to a poster presentation here.
Kamaljit S. Balaggan, MBBS, and colleagues presented a poster at the Association for Research in Vision and Ophthalmology meeting on the early results with the SMD-1 novel episcleral brachytherapy device developed by SalutarisMD. The class 1 medical device delivers 24 Gy of radiation for 5.5 minutes to the macula through a probe placed adjacent to the macular sclera via a sub-Tenon retrobulbar approach, according to the authors. The six patients treated in this study also received anti-VEGF injections.
The probe consists of a stainless steel cannula that is 1.8 mm in diameter.
The procedure was well-tolerated, and no serious adverse effects were reported, according to the authors. All patients experienced an increase in BCVA at 3 months, with a mean gain of 19 letters.
By 12 months, three patients maintained or improved BCVA, and three patients experienced a loss of BCVA. Two patients needed no further anti-VEGF injections at follow-up. All patients showed a reduction in macular thickness compared with baseline.
“This prospective study supports the safety and tolerability of this novel device and its further evaluation in planned larger phase 1/2 trials,” the authors said.
Disclosure: Balaggan is a consultant for SalutarisMD.