A 2×2 millimeter wireless retinal implant system helped many people with advanced geographic atrophy due to age-related macular degeneration regain functional central vision in a multicenter European study, according to results published in The New England Journal of Medicine.
Advanced atrophic age-related macular degeneration (AMD), also called geographic atrophy (GA), is a common cause of irreversible central vision loss in older adults and affects more than 5 million people worldwide, according to the study authors and a University of Pittsburgh research summary.
In the PRIMAvera clinical study (ClinicalTrials.gov identifier NCT04676854), researchers evaluated the PRIMA system—an implant-and-glasses setup intended to replace the function of lost photoreceptors in GA. The PRIMA system uses a 2×2 mm subretinal photovoltaic implant placed under the atrophic macula. A camera in specialized glasses captures images and projects near-infrared light onto the implant, which converts that light into electrical stimulation that can be relayed through surviving retinal circuitry to the brain. Users can adjust settings such as zoom and contrast.
The trial enrolled 38 participants aged 60 and older at 17 medical centers in five European countries—France, Germany, Italy, the Netherlands and the United Kingdom. The study was co-led by José-Alain Sahel (UPMC Vision Institute), Daniel Palanker (Stanford University) and Frank Holz (University of Bonn).
At 12 months, 32 participants were assessed. Among those 32, 26 (81%) met the study’s definition of a clinically meaningful improvement in visual acuity (at least 0.2 logMAR) when using the PRIMA system. Participants gained an average of 25 letters—about five lines—on a standard ETDRS eye chart with the implant. The report also noted that 27 of 32 participants (84%) said they were using the device at home to read numbers or words, and that one participant improved by 59 letters (about 12 lines).
In the University of Pittsburgh summary accompanying the publication, Sahel said the results marked an unusually strong outcome for vision-restoration efforts in this patient group and described patients’ regained ability to read letters and words, though he said the device does not restore full 20/20 vision.
Safety findings in the peer-reviewed paper included serious adverse events related to the procedure or device through 12 months; most occurred within two months after surgery and most resolved within two months after onset. The University of Pittsburgh summary also reported that, by 12 months, procedure-related side effects had resolved.
Regulatory and development efforts are ongoing. The University of Pittsburgh summary said the manufacturer, Science Corporation, had submitted applications seeking approval for clinical use in Europe and the United States. The same summary reported that UPMC became the first U.S. center to implant the PRIMA device in 2020 in a study led by Joseph Martel, M.D.
The New England Journal of Medicine paper lists funding from Science Corporation and the Moorfields National Institute for Health and Care Research Biomedical Research Centre.
