Scientific revelations discovered during Retina Implant’s first human clinical trial

Mar 18 2010

Retina Implant, AG, a leading developer of subretinal implants for the visually impaired, today announced scientific revelations discovered during the company’s first human clinical trial. The results achieved in the 11 patients that were involved in the trial exceeded the company’s expectations for their first trial. In fact, a few of the patients were able to see objects and shapes so clearly they could combine letters to form words and recognize foreign objects. Previous studies conducted by other companies’ also developing retinal implants have found their technology facilitated the ability to see light and outlines of objects, but did not produce a level of sight that enabled patients to read or recognize foreign objects. Retina Implant’s clinical trial began in Germany in 2005 and has involved 11 patients who lost their sight due to retinitis pigmentosa (RP).

“As an ophthalmic vitreo-retinal specialist I have been following the artificial vision space for some time now, and I am particularly interested in the progress of Retina Implant’s team”

Retinitis pigmentosa (RP) is one of the most common forms of inherited retinal degenerations affecting approximately 200,000 people in the world. A progressive condition that gets worse over time, RP typically causes severe vision problems in adulthood. While there are currently no approved treatment options that can restore vision for RP patients or impede the progression of the disease, retinal implants represent tremendous promise for enabling RP patients to regain sight.

There are two main approaches to retinal implants currently being studied by scientists across the globe; subretinal and epiretinal. The subretinal approach involves implanting the chip underneath the retina, specifically in the macular region. The macular region is believed to be the ideal location because this is the most sensitive area which is responsible for producing clear images in sighted people. By placing the chip below the retina, the natural way of processing light—through the pupil of the eye to the retina to the optical nerve and finally to the brain—can be restored. While, the epiretinal approach involves placing the chip on top of the macular region of the retina and requires additional equipment—like cameras or special glasses—to properly function.

“During the course of our first trial, we learned a great deal between our first and last patient, especially from patient 10 to 11,” said Dr. Walter-G. Wrobel, president and CEO of Retina Implant, AG. “Paramount in this discovery was learning that using the subretinal approach to place the chip in the macular region provided superior clinical outcomes. The eleventh/last patient in the study was the only one to have the chip placed exactly in the macular region, and he was able to see more clearly than any other patient in the trial. Additionally, every patient tolerated the surgery well; no adverse events occurred.”

“As an ophthalmic vitreo-retinal specialist I have been following the artificial vision space for some time now, and I am particularly interested in the progress of Retina Implant’s team,” said Dr. Jay Federman of the Retina division of the Wills Eye Institute in Philadelphia, Pa. “The results of the subretinal approach—implanting a 1,500 multi-electrode are very encouraging. It will be exciting to watch Retina Implant’s subsequent clinical trials as well as scientists at both the Massachusetts Institute of Technology (MIT) and the Stanford University group who are also researching the subretinal approach and plan to commence human trials. I’m hopeful this breakthrough research will present the blind community with a viable treatment option in the coming years. This whole field is evolving, and I believe will continue to push beyond our existing capabilities.”

“I first noticed my eyesight was impaired at 16, and over a period of 16-17 years, my condition deteriorated to complete blindness,” said the 11th patient, a 45 year-old Finland-based male. “I knew there was a chance the implant wouldn’t enable me to see anything, but I was willing to participate in the research with the hope I would regain some sight. When the microchip was turned on, I immediately was able to distinguish light from dark and see outlines of objects. As I got used to the implant, my vision improved dramatically. I was able to form letters into words, even correcting the spelling of my name. I recognized foreign objects such as a banana and could distinguish between a fork, knife and spoon. Most impressively, I could recognize the outlines of people and differentiate heights and arm movements from 20 feet away.”

Retina Implant is presenting results of this clinical trial at the Association for Research in Vision and Ophthalmology’s (ARVO) annual meeting May 2-6 in Fort Lauderdale, Fla.

SOURCE Retina Implant, AG