Retinal Implant Restores Vision in Advanced AMD, Study Finds

A groundbreaking clinical study published in the New England Journal of Medicine has shown that a wireless retinal implant can restore central vision in patients with advanced age-related macular degeneration (AMD), specifically in those with geographic atrophy (GA), the advanced atrophic form of AMD.

The international, multi-center trial, known as PRIMAvera, was co-led by José-Alain Sahel, MD (UPMC Vision Institute), Daniel Palanker, PhD (Stanford University), and Frank Holz, MD (University of Bonn, Germany). Results from this study mark a significant step forward in vision restoration technologies for patients affected by one of the world’s leading causes of irreversible blindness.

Clinical Outcomes: Meaningful Vision Restoration Achieved

Among the 32 patients who completed 12 months of follow-up, key findings included:

• 26 participants experienced clinically meaningful improvements in visual acuity

• 27 participants reported using prosthetic vision at home for reading words and numbers

• On average, participants improved by 25 letters (approximately five lines) on a standard eye chart

• 81% of participants gained 10 or more letters, and one participant improved by 59 letters (10 lines)

“It’s the first time that any attempt at vision restoration has achieved such results in a large number of patients,” said Dr. Sahel, chair of the Department of Ophthalmology at the University of Pittsburgh School of Medicine. “More than 80% of the patients were able to read letters and words, and some are reading pages in a book.”

How the PRIMA System Works

The PRIMA system, originally developed by Dr. Palanker, is designed to replace damaged photoreceptors in the retina. It consists of a 2×2 mm flexible wireless micro-implant that converts light into electrical signals, which then stimulate remaining retinal cells.

The system functions through a combination of implantable hardware and external components:

• A camera mounted on specialized glasses captures images

• Images are projected onto the implant using invisible near-infrared light

• The implant converts these images into electrical pulses, reestablishing visual signal transmission to the brain

• Patients can adjust zoom and contrast settings to enhance the quality of functional vision

This mechanism effectively restores the flow of visual information, allowing patients to regain some central vision previously lost to GA.

Study Scope and Global Participation

The PRIMAvera trial enrolled 38 participants aged 60 and older across 17 sites in France, Germany, Italy, the Netherlands, and the United Kingdom. After one year, all procedure-related adverse events had been resolved, and a majority of participants showed notable improvements in visual function.

“While we can't yet restore full 20/20 vision with the implant alone, we are exploring methods at UPMC that could enhance outcomes and help patients surpass the threshold for legal blindness,” added Dr. Sahel.

Regulatory Pathway and Ongoing Development

Following the success of the trial, Science Corporation, the device’s manufacturer, has submitted applications for clinical use authorization in both Europe and the United States. Notably, UPMC was the first U.S. center to implant the PRIMA device in a trial led by Joseph Martel, MD, associate professor of ophthalmology.

The study was supported by a broad consortium of investigators from leading institutions, including the University of Bonn; the Adolphe de Rothschild Foundation Hospital and the 15–20 National Eye Hospital in Paris; Moorfields Eye Hospital in London; and the University of Rome Tor Vergata.

Reference:

Vision Restoration with the PRIMA System in Geographic Atrophy Due to AMD, New England Journal of Medicine (2025). DOI: 10.1056/NEJMoa2501396