Clinical Trials Begin for Macular Degeneration Sight Restoration

Over the last several decades many research teams have been attempting to develop various remedies for macular degeneration. Currently in the pipeline is stem cell applications, 3-D printed retinas and advanced sight contact lenses. These and other developments are still in the trial stages with stem cells probably at the forefront.

A recently reported macular degeneration remedy technology called PRIMA (Photovoltaic Retinal Implant) seems to be advancing closer to mainstream applications more rapidly than previously thought.

This implant just may be amongst the few shining hopes of medical technology surpassing pharmaceuticals and surgery, for the time being. Currently, France is leading with approved human clinical trials. Discussions with the FDA for US trials are in the works.

Pharmiweb reported on the announcement of the approved French clinical trials stating,

“miniaturized wireless sub-retinal implant, PRIMA, to restore vision in patients affected by retinal dystrophies, received authorization from the French regulatory agency, Agence Nationale de Sécurité du Médicament et des Produits de santé (ANSM), to start a feasibility clinical study in patients with advanced dry age-related macular degeneration (dry-AMD).”

This is exciting news for millions (including about 4 million Americans ) suffering from loss of vision due to dry-AMD. It is an accelerated medical advancement that may possibly correct debilitating visual symptoms. As clinical trials begin for macular degeneration sight restoration tech, a door is opening on a whole new chapter in visual healing applications.

Inception to Patient

It was only about a year ago that PRIMA was reported on as a rising research option for macular degeneration. Now, Pharmiweb reports on the rapidly approaching future reality of this miniaturized wireless sub-retinal implant,

“Conceived initially by the researchers at Stanford University, and successfully developed through to clinical stage by our team at Pixium Vision in close collaboration with numerous physicians and scientists, PRIMA enters an exciting phase of its development, with a first patient expected to be implanted before year end [2017]. With aging population dynamics, advanced dry-AMD is a leading cause of irreversible vision loss [] with currently estimated over 4 million people without approved treatment option making it a significant unmet medical need.”

5 visually impaired patients will be chosen for this study being conducted at Paris’ Fondation Ophtalmologique Rothschildand Hôpital des Quinze-Vingt by principal investigator Dr. Yannick Le Mer. Evaluations will be conducted starting at 6 months up to 36 months. In this type of study, just three short years (or less) could determine if this unique technology will make it to the mainstream population.

Understanding the Disease

Although macular degeneration is a number one cause of vision loss, it is important to understand the inner workings of how this disease affects the anatomy of the eye.

Smithsonian explains macular degeneration as well as retinitis pigmentosa another vision robbing condition,

“The diseases target the photoreceptors, which are the rod- and cone-shaped cells at the back of the eye. These cells convert light into an electrical signal that travels to the brain via the optic nerve. Macular degeneration and retinitis pigmentosa break down these photoreceptors. [] Though the impacts are severe, not all hope is lost. The remainder of the retina’s neurons and cells that transmit the electrical signals are often left intact. That means that if scientists can rig a device that can essentially imitate the function of the rods and cones, the body can still process the resulting signals.”

PRIMA is exactly such a device which may soon become a reality.

The Tech

The PRIMA microchip implant developed by Pixium Vision will enable those with macular degeneration to essential override their disease. It consists of micro-panels wirelessly connected to a set of glasses with a video camera embedded in the center. The camera takes pictures of the surroundings and wirelessly transfers the images to a pocket computer for processing. Then the glasses beam the processed images to the eyes in the form of pulses of near infrared light. The PRIMA implant is almost as instantaneous as the natural process.

Reported by Mass Device,

“The Prima system is a next-gen wireless implant with a micro photovoltaic chip designed to be implanted under the retina to convert pulsed near-infra-red invisible light received from external glasses with an integrated mini-camera into electrical signals transmitted to the brain through the optic nerve,”

The microchip is 2mm long and 30 microns thick (smaller than the number one on a penny) equipped with 378 electrodes. It is implanted under the retina by a minimally invasive surgical procedure.

This hardware ingeniously uses state-of-the-art, micro-technology to advance visual acuity. Although it currently does not bring one back to perfect 20/20 vision, after the clinical trials (which the FDA may approv for almost 100% blind individuals) the chances of PRIMA rapidly advancing is almost inevitable.

In the conclusion of,‘Photovoltaic Restoration of Sight with High Visual Acuity

in Rats with Retinal Degeneration,’ a study by researchers at Stanford University, University of California Santa Cruz and University of Strathclyde, Glasgow, Scotland it was stated,

“If the spatial localization from our measurements will translate to the human retina, such prosthetic performance would correspond to visual acuity of 20/250, which is well below the legal blindness limit of 20/400, as defined by the World Health Organization. With the enhanced acuity provided by eye movements and perceptual learning in patients, visual acuity could perhaps cross the 20/200 threshold of legal blindness in the US.”

This conclusion continues with speculation that practically predicts an end to macular degeneration and possibly blindness as we know it,

“Such a wide range of safe stimulation may allow further reduction of the pixel size, up to a factor of 2. Ease of implantation and tiling of these wireless arrays to cover a large visual field, combined with their high resolution opens the door to highly functional restoration of sight.”

With minimal success in quelling or even curing macular degeneration, PRIMA gives an excellent workaround that has finally been embraced by the industry. In the near future, this and many other similar workarounds are the next generation of ophthalmology and medicine as a whole. It is a hope that millions have been waiting for to finally see again.