CONCERTO trial is seeking participants to evaluate the new SING IMT
Long-time members of our AMD community may remember FDA approval in 2010 of a unique device called Implantable Miniature Telescope (IMT). Our ensuing write-up described the device as a micro-sized precision telescope which provides magnification of up to 3 times and a 20º field of view. It is implanted in one eye in an outpatient surgical procedure conducted under local anesthesia. It has since been implanted in more than 600 patients (1) affected by late-stage age-related macular degeneration (AMD).
We now announce an improved version of the IMT offered by Samsara Vision (formerly VisionCare, Inc.) under the brand name SING IMTTM (Smaller-Incision New-Generation Implantable Miniature Telescope).
The new technology is essentially the same as the first generation IMT, in which the tiny telescope is implanted through an incision in the cornea. An important difference, however, is that it can be folded for pre-loading into a special delivery system enabling a smaller corneal incision and safer less complicated surgery.
The SING IMTTM is already approved in several countries, but not yet in the United States. Toward that end, Samsara has announced FDA approval to initiate a U.S.-based study to evaluate improvements in visual acuity and to ensure safety of the device in people living with late-stage age-related macular degeneration. The CONCERTO trial is now recruiting older adults living with non-active neovascularization (blood vessel growth), central blind spots in both eyes, and geographic atrophy or scarring of the fovea (the center of the macula).
Participants will receive a SING IMTTM in one eye. They must be aged 65 or older, cannot have had previous cataract surgery in the study eye, and must agree to post-operative rehabilitation and training. Both the operative and the non-study eye will be assessed pre- and post-operatively across five visits over 12 months. The CONCERTO trial will take place in up to twenty U.S. clinical sites including California, Florida, Massachusetts, New Jersey, Pennsylvania, Wisconsin. Follow this link for complete details about the trial and locations.
The SING IMTTM is not a cure for late-stage dry (geographic) AMD. It will not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. The technology, however, has been shown to significantly improve vision and quality of life for individuals with this incurable disease. (2)
To learn more about the study and inquire about participation, visit www.concertostudy.com.
1. In addition to the 217 patients implanted during the pivotal trial, once FDA marketing authorization was received, and CE marketing outside of the US was granted, the device has also been implanted in 400+ patients commercially to reach more than 600 patients.
2. Hudson HL, Lane SS, Heier JS, et al; IMT-002 Study Group. Implantable miniature telescope for the treatment of visual acuity loss resulting from end-stage age-related macular degeneration: 1-year results. Ophthalmology. 2006;113(11):1987-2001.
Dan Roberts, Editor
Living Well With Low Vision