PRZOOM - /newswire/ -
Maui, Hawaii, United States, 2012/01/18 - At Retina Meeting 2012 today, Reid Schindler, M.D., presented positive Phase I data from a human study designed to assess a new investigational therapy to treat Wet Age-related Macular Degeneration (Wet AMD) - SalutarisMD.com.
Dr. 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 the standard Wet AMD therapy using anti-VEGF injections given as induction, and additional anti-VEGF injections as needed.
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 (SAE) in the study, nor any Unanticipated Adverse Device Effects (UADE).
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.
“What is most intriguing about the study is that the application of radiation is done through the posterior sclera, thus avoiding the need for vitreous surgery,” said Dr. Schindler, a clinical ophthalmologist and retina specialist with Retina Specialists of Southern Arizona, and clinical associate professor, University of Arizona department of ophthalmology.
Schindler described the study’s surgical technique, reporting that,“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.”
The 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 the same clinical environment as current anti-VEGF injections: a physician’s office or outpatient setting under local anesthesia in approximately 15 minutes.
Baldassarre Stea, M.D., Ph.D., co-principal investigator of the study, professor and head of the University of Arizona department of radiation oncology, said,“What I like most about the SalutarisMD radiation delivery procedure is its simplicity: A hand-held, visually-guided device is applied over the surface of the sclera for only a few minutes."
Michael Voevodsky, president and CEO of SalutarisMD, said,“Based on the study results, we believe our investigational therapy for treating Wet AMD has the potential to improve the quality of life for those suffering from this debilitating disease. We are excited to continue clinical studies to further test our approach and its ability to positively impact outcomes, costs and treatment burden for Wet AMD.”
Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.
Salutaris Medical Devices, Inc. (SalutarisMD.com) is a privately held clinical-stage medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss.
About the University of Arizona Health Sciences Center
The Arizona Health Sciences Center (AHSC) at the University of Arizona is a network of health-related organizations and activities unique in the state and region. Arizona’s only academic health sciences center, AHSC is based on the campus of the University of Arizona in Tucson and maintains a growing presence on the Phoenix Biomedical Campus in downtown Phoenix. From these vantage points, AHSC reaches across Arizona and well beyond its borders to provide health-care education, research, patient care and service for Arizonans and their neighbors today and for the future.
Editor's Note: For images of Dr. Reid Schindler, Michael Voevodsky and the SalutarisMD devise diagram, please contact Linda Cohen.