1.WHAT IS A CLINICAL STUDY?
A clinical study is research with human participants. Its goal is to address specific questions on a new treatment (for example medical device, vaccine, new therapies, or new indication for known treatment). Such a study allows to determine the safety and/or efficacy profile of a new medical technology or treatment in general.
2.WHAT ARE PRIMA-US-FS AND PRIMA-FS STUDIES?
PRIMA-US-FS clinical studys a feasibility clinical research study conducted in United States, in two centers in Miami and Pittsburgh, to evaluate the Prima System, parallel to a similar feasibility study conducted in France in Paris (PRIMA-FS) which successfully completed implantations of 5 patients. The first results at 6 months from the study in France were reported during the American Academy of Ophthalmology AAO annual meeting held in Chicago in October 2018 and interim 1 year follow-up results were announced by the company in July 2019.
3.HOW DOES Prima SYSTEM WORK?
The Prima System aims to elicit useful prosthetic bionic vision by electrical stimulation of the retina and therefore partially compensating the loss of natural central vision. Learn more about the Prima System.
4.FOR WHAT TYPE OF VISION LOSS IS THE Prima SYSTEM?
In Both clinical feasibility studies, the Prima System is intended for patients with Advanced Atrophic Dry Age-Related Macular Degeneration (dry-AMD) also known as geographic atrophy. In these two feasibility studies the Prima System is NOT eligible for other vision loss such as:
- Wet Age Macular Degeneration,
- Retinitis Pigmentosa,
- Glaucoma etc.
If you have Dry AMD, other inclusion criteria may apply. Please refer to question number 7 of this FAQ to learn more about inclusion criteria. Please note that the recruitment for PRIMA study in Paris is closed. Following clinical studies will be announced by the company.
5.HOW MANY PATIENTS WILL PARTICIPATE IN THE STUDIES?
Two separate clinical studies (one in France and the other in USA) are being conducted for people with advanced atrophic dry age-related macular degeneration, with profound central vision loss. All 5 patients have already been successfully implanted in the European feasibility study. Recruitment for the separate feasibility clinical research study in USA is fully active in Pittsburgh and Miami, where a total of 5 patients will be implanted.
6.CAN I STILL PARTICIPATE IN THE PRIMA STUDY?
All 5 patients have already been successfully implanted for the PRIMA-FS study in France, so it is not possible to enter the French PRIMA-FS Feasibility study anymore. However, if you live in Europe, and have dry AMD, you may be eligible for our future European multicenter study which is not yet recruiting. Please visit our website which will be updated with further details concerning participating clinical sites.
If you live in the United States of America, you can still participate in the PRIMA-FS-US feasibility study being conducted in Pittsburgh and Miami and which is still recruiting patients.
7.I have dry AMD, is this the only condition I need to have to be able to participate in the PRIMA-FS-US Study in USA?
In addition to be diagnosed with dry age related macular degeneration, other inclusion criteria apply in PRIMA-US-FS study,. Main criteria are :
- 60 years or older
- Visual Acuity of 20/400 (5% or 0,05) or worse in the worse seeing eye
- No foveal perception
Further criteria apply. Please find more details about inclusion and exclusion criteria for the study being conducted in USA at clinicaltrials.gov link.
To check your eligibility for the PRIMA-US-FS study being conducted in Miami or Pittsburgh, please refer to the participating center, the UPMC Eye Hospital Pittsburgh by phone : 412 647 3434 or the Miami Bascom Palmer Eye Institute by phone 305-326-6111
8.WHAT IS THE PURPOSE OF THE STUDIES, HOW CAN I BENEFIT?
The objective for the French feasibility study is to assess safety and elicitation of visual perception by electrical stimulation of the central retina with the Prima System. The PRIMA wireless photovoltaic subretinal implant under investigation has already been implanted successfully in five patients in France, enabling elicitation of light perception in all 5 implanted subjects.
In US the objective is to assess the safety and the device performance by measuring the visual acuity.
For these patients who no longer had natural central vision, the Prima System enabled the majority of them to begin to correctly identify patterns, numbers and letters. The implanted device is well tolerated, with no device-related serious adverse events.
9.WHAT ARE THE POSSIBLE RISKS OR SIDE EFFECTS?
There are risks related to the Prima System and to the implantation surgery and they will be discussed with you by the study doctor and will also be detailed in the patient consent form.
10.WHERE DOES THE US STUDY TAKE PLACE AND WITH WHOM?
The study currently enrolling take place at the UPMC Eye Center in Pittsburgh PA, with the principal investigator Joseph Martel, MD. Tel: 412 647 3434 and also at the Miami Bascom Palmer Eye Institute with the principal investigator Prof. Byron L Lam, phone .305-326-6111
The study requires several follow-up visits and rehabilitation sessions after the implantation.
11.HOW LONG DOES THE STUDY TAKE AND HOW OFTEN SHOULD I EXPECT TO VISIT THE CLINIC?
Study follow-up after implantation lasts up to 36 months. In addition to personalized training and rehabilitation program performed throughout the study participation, medical follow-up exams are performed. The patient is expected to attend the rehabilitation session to gain experience and to optimize the usage of the Prima System.
12.WILL MY EXPENSES AND TRAVELING TO THE SITE BE COVERED?
By participating in the research study, the clinical research related expenses, including accommodation, transport and food during the study will be covered. All these expenses will be covered.
13.HOW WILL MY PERSONAL DATA CONFIDENTIALITY BE GUARANTEED?
The information related to you which will be used outside of the clinic, will not mention your name, date of birth or your contact details, or any information that would identify you.
14.CAN I WITHDRAW FROM THE STUDY?
Your participation in the research study is voluntary. You can choose to withdraw from the study at any time without giving a reason. There will be no penalty or loss of eligible expenses for the period covering your study participation, if you decide to not continue participating in the study.
15.CONTACT FOR FURTHER INFORMATION
Further questions concerning this clinical feasibility study will be answered by the study doctor or trial coordinator at the participating sites. They will be glad to answer any questions you might have about your rights as a participant in the present clinical research study.
Thank you for your interest in the PRIMA Study.
Please contact the participating clinic if you have further questions :
Pittsburgh : 412 647 3434
Miami : 305-326-6111