Clinical trial will test use of retinal prosthesis to treat advanced age-related macular degeneration.
UPMC has implanted the first patient in the United States with a new wireless retinal device as part of a clinical trial aimed at restoring partial sight to patients with advanced age-related macular degeneration (AMD), a disease that leads to permanent blindness.
“Vision research has advanced dramatically in the recent past and UPMC is at the forefront of this revolution. This is the first of many such breakthroughs led by UPMC and Pitt that will benefit patients with vision loss in our community and around the world,” said José-Alain Sahel, M.D., director of the UPMC Eye Center, Eye and Ear Foundation chair of ophthalmology and distinguished professor at the University of Pittsburgh School of Medicine who initiated the trial at UPMC. “We are proud to be the first center in the United States to test this next generation retinal implant that could help treat an incurable disease like AMD.”
The system, called PRIMA, is designed to restore sight in patients blinded by retinal degeneration. It consists of a 2×2 millimeter, 30-micron thick miniaturized wireless photovoltaic chip, placed under the damaged retina and works in tandem with augmented reality glasses that have a built-in miniaturized camera and infrared projector.
The chip acts like a tiny artificial retina, made up of 378 tiny electrodes that convert infrared light from the glasses to electrical signals that are carried by the optic nerve to the brain. After receiving the implant, patients undergo an intensive rehabilitation program that trains their brains to understand and interpret the signals from the implant in combination with their remaining natural vision. Compared to earlier-generation implants, PRIMA is wireless and has significantly more electrodes, which allows for the transmission of more visual information.
“This is an incredibly exciting first for us at UPMC and I’m honored to be a part of it,” said Joseph Martel, M.D., the implanting surgeon at the UPMC Eye Center and the Pitt School of Medicine, and the principal investigator of the trial at UPMC. “I’m grateful to our patients who have volunteered to participate in this trial, without whom this would not be possible.”
AMD is the leading cause of vision loss in people older than 50. Today, it affects approximately 14 million people in the United States, and the prevalence is expected to rise as the baby boomers age. As AMD progresses, the center of vision becomes increasingly blurry. “Atrophic” AMD, which accounts for a large proportion of advanced cases, has no curative treatment available.
The UPMC feasibility trial is running in parallel with the first-in-human trial in France, which involves five patients with advanced AMD, who now have been followed for more than a year. The 12-month results from the French study demonstrated the ability of most patients to identify sequences of letters and there were no device-related serious adverse effects.
“We are working with a great sense of urgency because the aging population of the United States, especially the western Pennsylvania region we live in, will see a significant rise in the number of patients at risk for vision loss through diseases like age-related macular degeneration, glaucoma and vascular eye disease, as well as earlier onset genetic conditions such as retinitis pigmentosa,” said Sahel. “This is why our physicians and researchers at UPMC and Pitt, in collaboration with our U.S. and international colleagues — especially at the Paris Vision Institute at Sorbonne University — are taking a multi-pronged effort to treat and rehabilitate patients with vision impairments.”
In March 2019, UPMC broke ground on the UPMC Vision and Rehabilitation Tower at UPMC Mercy, which when completed, will provide advanced specialty clinical care and innovative programs for visually impaired patients. It also will be the home for the vision research program at Pitt and UPMC.
The PRIMA implant was invented by Daniel Palanker, Ph.D., professor of ophthalmology at Stanford University, and licensed and developed by Pixium Vision, a spin-off from the Paris Vision Institute. Sahel is a co-founder of Pixium and holds shares in the company.