| Enrolment has begun in a Salutaris Medical Devices, Ltd. (SalutarisMD®) sponsored observational study conducted at Moorfields Eye Hospital NHS Foundation Trust. In 2013, Moorfields and SalutarisMD announced their collaboration to advance the research and development of a novel medical device for use in the treatment of wet age-related macular degeneration (AMD), the leading cause of vision loss and blindness.
The purpose of this study is to accurately measure the scleral and choroid thickness at the fovea and at the choroidal neovascular lesion. This new observational study (“A Prospective Study to Determine Choroidal and Scleral Depth in Subjects with Neovascular Age-related Macular Degeneration Receiving Anti-VEGF Therapy”) will use three imaging modalities to determine the depth from the retrobulbar episcleral surface to the vitreous side of the sclera, choroid, and retina at the centre of the fovea and choroidal neovascularisation (CNV).
The SalutarisMD device employs a minimally invasive retrobulbar episcleral brachytherapy application to the neovascular membranes. The differentiation and measurement of the retina, choroid and sclera layers is of particular importance in determining the depth from the outer surface of the eye, through the choroid, to the apex of the CNV. Distance from the episcleral surface to the choroidal lesion is the key to delivering the appropriate prescribed radiation dose.
Enrollment of study subjects is ongoing. “We are very excited to initiate this study with our research collaborators at Moorfields Eye Hospital,” said Dr. Laurence Marsteller, Managing Director of SalutarisMD Ltd. “The resultant data will bring us closer to offering this new therapy to patients suffering wet AMD.”
Wet AMD has a profoundly negative impact on quality of life and imposes a considerable financial burden on healthcare systems. An estimated 70 percent of patients with wet AMD will experience severe vision loss within two years of receiving the diagnosis. There is an urgent and compelling need for new therapies that improve visual outcomes and lower the burden of care. The SalutarisMD device has the potential to accomplish these aims by reducing the need for repeated monthly injections and eliminating or extending the period between treatments. |
