Active not recruitingNAINTERVENTIONAL

Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD

This research study is investigating a new system, called PRIMA Bionic Vision, for individuals living with geographic atrophy, which is a severe form of age-related macular degeneration (AMD). Geographic atrophy causes a blind spot in your central vision, making everyday tasks difficult. The study's main goals are to find out how well the PRIMA system works to restore some central vision and to ensure it is safe for patients. Participants will have a small device, the PRIMA Implant, placed in their eye. Over time, their vision will be regularly checked using different tests to see the impact of the system, including how it might improve their ability to do daily activities. This is an important step in developing new ways to help those affected by this challenging eye condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Science Corporation

Enrolment target

Start

24 Nov 2020

Estimated completion

01 Mar 2029

Geographic Atrophy

What is this study about?

This study is exploring a new technology called the PRIMA Bionic Vision System for people who have a condition called geographic atrophy. Geographic atrophy is an advanced type of age-related macular degeneration (often called AMD). AMD affects the macula, a small but vital part of your retina responsible for sharp, central vision – the vision you use for reading, recognising faces, and driving. In geographic atrophy, the cells in the macula wear away, leading to a permanent blind spot in the middle of your vision.

The PRIMA system is a type of bionic eye technology. It involves a tiny implant, similar in size to a poppy seed, that is placed in the eye. This implant is designed to take over the job of damaged cells in the retina. When connected to a special pair of glasses that processes images, it aims to help people perceive shapes and light again, potentially restoring some useful central vision.

The main purpose of this study is to carefully look at how well the PRIMA system works to help restore central vision and, equally important, to make sure it is safe for patients. Researchers will assess participants' vision through various tests at different times after the implant procedure. This will help them understand if the PRIMA system can genuinely improve vision and quality of life for people with geographic atrophy.

Key takeaways

Tests the PRIMA Bionic Vision System for geographic atrophy (severe AMD).
Aims to restore some central vision and assess safety.
Involves a small implant placed surgically in one eye.
Participants will have regular vision assessments.
Only for people aged 60+ with very poor central vision due to geographic atrophy.
Participation involves eye surgery and multiple follow-up appointments.

Who may be eligible?

To be considered for this study, you would need to be 60 years old or older and have a confirmed diagnosis of geographic atrophy in both eyes. Crucially, your central vision in the eye being studied must be very poor, making it difficult to read even large print. The area of damage in your eye must also be large enough for the tiny implant. You also need to be able to attend all scheduled follow-up appointments and understand what is involved in taking part.

There are also several reasons why you might not be able to join. For example, if you have a significant cataract in the study eye that hasn't been dealt with, or if you've recently had eye surgery. People with extremely short-sighted or long-sighted eyes, or those with no light perception in either eye, would also not be suitable. Any history of ‘wet’ AMD (another form of AMD where abnormal blood vessels grow), or other serious eye conditions like severe glaucoma or diabetic eye disease, would also exclude you.

Also, if you have any condition that would prevent a clear view of your eye during examinations, you might not be eligible. The research team needs to be sure your eyes are otherwise healthy enough for the implant and to be clearly monitored throughout the study.

Quick self-check

Are you 60 years old or older?
Have you been diagnosed with geographic atrophy in both eyes?
Is your central vision in the eye being considered for the study very poor (e.g., struggling to read large print)?
Are you able to attend all necessary follow-up appointments?
Have you had no recent eye surgery (within the last month)?
Do you have no other serious, uncontrolled eye conditions like severe glaucoma or 'wet' AMD?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first undergo a screening process to ensure you meet all the requirements. If eligible, you would then have a small PRIMA Implant surgically placed in one of your eyes. Following the surgery, you will have regular check-ups at different times. These appointments will involve various eye tests to see how your vision is changing and how well the PRIMA system is working. You will also be assessed on how the system helps you with everyday tasks. The study involves ongoing monitoring and assessments, and the full duration of your participation, including all follow-up visits, would be discussed in detail with the study team. You won't be taking any specific study medication, but you'll be using the PRIMA Implant and its accompanying visual processor.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of restoring some central vision, which might help with daily activities for people with severe geographic atrophy. However, as with any surgical procedure, there are potential risks, including those associated with eye surgery itself, such as infection or bleeding, and risks related to the implant. The exact nature and likelihood of these risks would be fully explained before you consent to participate. You would also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

Hôpital de la Croix-Rousse CHU de LYON
Lyon, France
Hôpital Pellegrin
Bordeaux, France
Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
Créteil, France
Centre Monticelli Paradis
Marseille, France
CHU de Nantes
Nantes, France
Hopital des Quinze Vingts
Paris, France
Fondation Ophtalmologique A. De Rothschild
Paris, France
Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
Aachen, Germany
Universitäts-Augenklinik Bonn
Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik
Hamburg, Germany
Klinikum Ludwigshafen -Augenklinik
Ludwigshafen am Rhein, Germany
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, Germany

+9 more sites — see the official record for the full list.

Common questions

What is geographic atrophy?

Geographic atrophy is an advanced form of age-related macular degeneration (AMD) where the cells in the centre of your retina (the macula) waste away, causing a blind spot in your central vision.

What is the PRIMA Bionic Vision System?

It's a new technology that involves a small implant surgically placed in the eye, designed to help people with severe central vision loss perceive light and shapes, potentially restoring some vision.

Will I get my full eyesight back?

The goal is to restore some useful central vision, not necessarily to return to full, normal eyesight. The study aims to understand how much improvement is possible.

Is the implant visible?

The implant is very small and is placed inside the eye. It is not designed to be externally visible or noticeable.

How long does the study last?

The specific duration of your participation, including all follow-up visits after the implant, would be explained in full by the study team before you join.