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Prospective phase I safety and tolerability evaluation of a novel minimally-invasive episcleral brachytherapy device for the treatment of exudative age-related macular degeneration (eAMD): twelve month results

Session Details

Session Title: AMD I

Session Date/Time: Thursday 26/09/2013 | 08:30-10:30

Paper Time: 09:42

Venue: Hall 1 (Level 2)

First Author: K.Balaggan UK

Co Author(s):    L. Joffe   R. Schindler   L. Marsteller   B. Stea     

Abstract Details

Purpose:

To evaluate the safety/feasibility of a novel episcleral brachytherapy device (SMD-1) for eAMD. Although anti-VEGF treatments have revolutionised the management of eAMD, they fail to significantly improve vision in the majority of patients. As neovascular regression is not achieved, many patients will likely require lifelong and frequent invasive intravitreal injections. Radiation has multiple angiostatic properties which could address these issues, and has recently been evaluated using both vitrectomy and stereotactic external beam delivery methods. These approaches are either invasive with predictable adverse effects or necessitate large complex expensive devices. A locally-delivered non-penetrating brachytherapy approach could overcome these limitations.

Setting:

University of Arizona, Department of Ophthalmology

Methods:

6 patients received 24Gy radiation over 5.5 minutes directly to the macular CNV by positioning the SMD-1 brachytherapy probe adjacent to the macular sclera via a subtenon retrobulbar approach. The probe was then removed. Patients also received concomitant anti-VEGF injections with further readministration as-needed. Adverse effects and changes in BCVA and macular thickness were evaluated monthly.

Results:

The procedure was readily performed and was well tolerated with no serious adverse effects. At 3 months, all patients experienced increases in BCVA (mean +19 ETDRS letters). By 12 months, 3 patients continued to demonstrate improved or stabilised BCVA (mean +7 letters), 2 of whom required no further anti-VEGF injections during follow-up. All patients demonstrated reduced macular thickness compared with baseline. Three patients demonstrated reductions in BCVA.

Conclusions:

This prospective study supports the safety and tolerability of this novel device, and its further evaluation in planned larger phase I/II trials.

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