Jan 2, 2023

Late-Stage AMD Patients Needed: Study Underway to Evaluate a New-Generation Implantable Miniature Telescope

In 2010, the U.S. Food and Drug Administration (FDA) approved a novel device from Samsara Vision called the Implantable Miniature Telescope (IMT). The purpose of this device is to magnify what a
person living with late-stage, age-related macular degeneration (AMD) is seeing in “straight-ahead” central vision and project this image onto undamaged sections of the retina, enabling that person to
recognize and identify objects that could not otherwise be seen. Patients may learn 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™ (Smaller-Incision NewGeneration Implantable Miniature Telescope) 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 (FDA) 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.

Are you or someone you love a potential candidate for this study? Here’s what to know:
• The study will last about 12-15 months, and both the treated and the non-study eye will be
examined in five visits over 12-15 months with a study care provider.
• The SING IMT™ will be implanted in an out-patient procedure into one eye to improve visual acuity
• Participants must be at least 65 years old on the pre-operative visit date 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 (up to 10 over 12 months) with a low-vision occupational therapist who will help train the SING IMT™ recipient on using the new implant.

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.
Patients/Caregivers: learn more about joining the study at www.concertostudy.com or call 1-866-393-3767
Physicians: Interested in referring late-stage AMD patients to the CONCERTO study?
• Visit www.concertostudy.com for more information and to complete the contact information
section for a potential patient. The patient will be contacted for a pre-screening discussion
within 72 hours.
• Call 1-866-393-3767 to speak to a clinical study representative.
• Have the patient/caregiver call 1-866-393-3767 to discuss eligibility, potential participation, and to answer any questions they may have.V1.0

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. Individual results may vary.

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