Wet AMD therapy study using fiber-optic light device yields positive results

At the Retina Meeting 2012 (Maui, HI) held recently, Reid Schindler, MD, presented positive Phase I data from a human study assessing a new, minimally invasive device to treat wet age-related macular degeneration (wet AMD), which causes vision loss and blindness. Salutaris Medical Devices (SalutarisMD; Tucson, AZ) developed the device—which incorporates a fiber-optic light tip—and sponsored the study.

Schindler, in his presentation, "Episcleral Brachytherapy In The Management of Age-related Choroidal Neovascularization," reviewed the short-term safety study, which applied 24 Gy single-fraction beta brachytherapy to the subfoveal neovascular membrane of the eye to treat wet AMD. The study subjects received standard wet AMD therapy using anti-VEGF injections given as induction, and additional anti-VEGF injections as needed.

"Under guidance of indirect ophthalmoscopy, the SalutarisMD brachytherapy probe was placed under Tenon’s capsule and gradually advanced posteriorly utilizing the fiber-optic light tip for localization. The position of the tip was adjusted while visualizing the light and fundus landmarks, thus centering the radiation delivery over the neovascular membrane," reports Schindler.

Schindler, principal investigator of the study, reported the Phase I study data of the six subjects treated to date, comprised of persistently treated subjects and newly diagnosed subjects with either classic or occult neovascular lesions. The investigators placed the SalutarisMD device and delivered the brachytherapy dose with ease and minimal subject discomfort. There were no reported serious adverse events (SAEs) in the study, nor any unanticipated adverse device effects (UADEs).

While the study is not intended to be extrapolated for statistical significance and follow-up is short, individual subject results were tracked. All study subjects had an improvement in vision as measured by best corrected visual acuity and none experienced a loss of vision; four subjects gained equal to or greater than 15 ETDRS letters of vision; five subjects experienced a decrease in macula thickness and absorption of subretinal fluid and hemorrhage; the macula thickness for the sixth subject was essentially unchanged; three subjects were found to be clinically dry during the study period and required no additional anti-VEGF injection.

Schindler, a clinical ophthalmologist and retina specialist with Retina Specialists of Southern Arizona, and clinical associate professor, University of Arizona Department of Ophthalmology, notes that application of radiation is done through the posterior sclera, thus avoiding the need for vitreous surgery.

The handheld, visually guided SalutarisMD device used in the Phase I study is designed to enable retina specialists to provide a practical, minimally invasive procedure that can be completed in a clinical environment, such as a physician’s office or outpatient setting under local anesthesia in approximately 15 minutes.

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