PRIMA Retinal Prosthesis for Dry Age-Related Macular Degeneration
(PRIMA-FS-US Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, it may need to be adjusted for eye surgery.
Is the PRIMA Retinal Prosthesis safe for humans?
Research on a similar type of retinal prosthesis in rats showed it was well tolerated with only a modest tissue reaction that decreased over time. Additionally, studies on related retinal implants in humans for macular degeneration have shown they can be safely implanted without significant adverse effects.12345
How is the PRIMA treatment for dry age-related macular degeneration different from other treatments?
The PRIMA treatment is unique because it uses a subretinal prosthesis, which is a small device implanted under the retina to electrically stimulate the remaining retinal cells, helping to restore vision. This approach is different from other treatments as it directly targets the retinal neurons to preserve natural signal processing, offering a novel way to address vision loss in dry age-related macular degeneration.24678
What data supports the effectiveness of the PRIMA treatment for dry age-related macular degeneration?
Who Is on the Research Team?
Joseph Martel, MD
Principal Investigator
UPMC Pittsburgh
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Treatment
Implantation of the PRIMA device and initial setup with the visual processing system
Monitoring and Adjustment
Participants undergo regular monitoring and adjustments to the device settings
Long-term Follow-up
Participants are monitored for safety and effectiveness of the device
What Are the Treatments Tested in This Trial?
Interventions
- PRIMA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Science Corporation
Lead Sponsor
Pixium Vision SA
Lead Sponsor
Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA
Collaborator