The CONCERTO study is actively seeking candidates with late-stage Age-related Macular Degeneration (AMD) for the SING IMT, who can participate from sites across the United States, including two in New Jersey.

New Jersey-based Samsara Vision, a medical device company that focuses on improving vision loss, is seeking participants with late-stage Age-related Macular Degeneration (AMD) for a clinical study of an investigational device called the SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) at sites in Eatontown and Whippany. What is the SING IMT? In 2010, the U.S. Food and Drug Administration (FDA) approved a novel device from Samsara Vision (formerly VisionCare, Inc.) called the Implantable Miniature Telescope (IMT). This device magnifies what a person living with AMD is seeing in “straight-ahead” central vision and projects this image onto undamaged sections of the retina, enabling that person to recognize or identify people or objects that could not otherwise be seen. Some patients are able to recognize the faces of friends and family and resume activities that they once enjoyed, like watching TV and reading.

Now, an investigational, new version of the IMT, called the SING IMT, is being evaluated for improvements in visual acuity and safety of the device in people living with late-stage AMD as part of the CONCERTO study, a U.S.-based Food and Drug Administration-regulated study. Already approved in Europe, the SING IMT design differs from the original device since it can be folded and inserted through a device delivery system that allows for a smaller incision and less complicated surgery.

Already approved in Europe, the SING IMT design differs from the original device since it can be folded and inserted through a device delivery system that allows for a smaller incision and less complicated surgery.

The CONCERTO study is actively seeking candidates for the SING IMT, who can participate from sites across the United States, including two in New Jersey. Here’s what to know:

• The study will last about 12-15 months, and the implanted eye will be examined in five visits over 12–15 months with a study care provider.
• The SING IMT will be implanted during an outpatient procedure into one eye
• Participants must be at least 65 years old and must have decreased vision associated with late-stage AMD.
• Participants cannot have had previous cataract surgery in the study eye.
• There will be separately scheduled visits with a low vision occupational therapist, who will help train the SING IMT recipient on using the new implant. (Up to 10 vision rehabilitation visits scheduled over 12 months to learn how to best use the implanted device as well as daily at-home exercises.)

Are you or someone you know a candidate for the SING IMT? The study will take place at sites across the country and is currently enrolling in California, Florida, Massachusetts, New Jersey, North Carolina, Pennsylvania and Wisconsin.

Learn more about joining the study at concertostudy.com.

The SING IMT is not a cure for late-stage AMD. It will not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. The most common risks of the SING IMT surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it and can damage the eye structures surrounding the device. Some patients also had further surgery to treat complications or to remove the device. The SING IMT device is expected to lead to loss of the peripheral vision in the surgical eye and the ability to ambulate (walk around) after receiving the SING IMT will be almost entirely dependent on the peripheral vision in the nonsurgical eye. Individual results may vary. Message sponsored by Samsara Vision.