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Retinal Prosthesis
PRIMA Retinal Prosthesis for Dry Age-Related Macular Degeneration (PRIMA-FS-US Trial)
N/A
Waitlist Available
Led By Joseph Martel, MD
Research Sponsored by Pixium Vision SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is 60 years or older at the date of inclusion
Meets one of the following criteria in the non-study eye: Visual acuity of 20/200 (logMAR 1.0) or worse and an atrophy size <8mm2, Visual acuity of 20/160 (logMAR 0.9) or worse and an atrophy size ≥8mm2 and ≤12.5 mm2, Visual acuity of 20/100 (logMAR 0.7) or worse and an atrophy size >12.5 mm2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 18, 24, and 36 months after implantation
Awards & highlights
PRIMA-FS-US Trial Summary
This trial is testing a new retinal prothesis for safety and performance in subjects with dry age related macular degeneration.
Who is the study for?
This trial is for individuals aged 60 or older with severe vision loss due to atrophic dry age-related macular degeneration. Participants must have specific levels of visual acuity and central scotoma in the study eye, meet certain criteria in the non-study eye, and be able to attend all follow-up visits. People with implanted devices, active cancer, severe organ diseases, unrealistic expectations, or those who cannot legally consent are excluded.Check my eligibility
What is being tested?
The PRIMA feasibility study tests a new retinal prosthesis device in five subjects with atrophic dry AMD to assess its safety and performance. The goal is to determine if this technology can improve visual function in patients with significant vision impairment from AMD.See study design
What are the potential side effects?
While specific side effects are not listed for this early-stage trial, potential risks may include discomfort at the implant site, inflammation or infection of the eye, changes in vision or visual perception issues related to the device.
PRIMA-FS-US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
My other eye has poor vision and a specific level of damage.
Select...
I have been diagnosed with advanced dry age-related macular degeneration.
Select...
I agree to attend all my follow-up appointments.
PRIMA-FS-US Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9, 12, 18, 24 and 36 months after implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12, 18, 24 and 36 months after implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Near Visual Acuity
Quality of Life
Reading Acuity Test
+1 morePRIMA-FS-US Trial Design
1Treatment groups
Experimental Treatment
Group I: PRIMAExperimental Treatment1 Intervention
Implantation of PRIMA device
Find a Location
Who is running the clinical trial?
Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SAUNKNOWN
Pixium Vision SALead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled
Joseph Martel, MDPrincipal InvestigatorUPMC Pittsburgh
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had abnormal blood vessel growth in my eye.I have a condition that makes it hard to examine my eyes properly.My eye pressure is either too low or too high.I have ongoing inflammation or infections.My study eye's retinal function is not affected by conditions other than those allowed in the study.I am unable to understand or sign the consent form due to mental incapacity.I am on blood thinners that can't be adjusted for eye surgery.I have a history of seizures.I do not have chronic infections that would stop me from joining the study.I do not have severe kidney, heart, or liver diseases.I have signed the informed consent form.I am 60 years old or older.My other eye has poor vision and a specific level of damage.I have been diagnosed with advanced dry age-related macular degeneration.I have a cataract in one of my eyes.I have an eye without its natural lens.I agree to attend all my follow-up appointments.I have nystagmus or another eye movement disorder.I have or had cancer in my eye, optic nerve, brain, or its spread.I understand the realistic outcomes of this trial.
Research Study Groups:
This trial has the following groups:- Group 1: PRIMA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for potential participants to join this research?
"As per clinicaltrials.gov, this experiment is currently seeking participants. First posted on April 26th 2018 and last updated June 6th 2022."
Answered by AI
How many participants are currently enrolled in this experiment?
"This study necessitates that 5 eligible participants enroll in the trial. Potential patients can take part from various locations such as Bascom Palmer Eye Institute in Miami, Florida and Byers Eye Institute-Stanford University in Palo Alto, California."
Answered by AI
Who else is applying?
What site did they apply to?
Byers Eye Institute-Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have RP Im applying for this trail is a hope for me to be able to safe part of my vision.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How does the trail work? What is it based on?
PatientReceived 1 prior treatment
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