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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 Science Corporation
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
Must not have
Has a history of choroidal neovascularization in either eye
Has any disease or condition that prevents adequate examination of the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, and 36 months after implantation
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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My other eye has poor vision and a specific level of damage.
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I have been diagnosed with advanced dry age-related macular degeneration.
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I agree to attend all my follow-up appointments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had abnormal blood vessel growth in my eye.
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I have a condition that makes it hard to examine my eyes properly.
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My eye pressure is either too low or too high.
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I have ongoing inflammation or infections.
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My study eye's retinal function is not affected by conditions other than those allowed in the study.
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I am unable to understand or sign the consent form due to mental incapacity.
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I am on blood thinners that can't be adjusted for eye surgery.
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I have a history of seizures.
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I do not have severe kidney, heart, or liver diseases.
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I have a cataract in one of my eyes.
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I have an eye without its natural lens.
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I have nystagmus or another eye movement disorder.
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I have or had cancer in my eye, optic nerve, brain, or its spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 18, 24, and 36 months after implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 18, 24, and 36 months after implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Near Visual Acuity
Quality of Life
Reading Acuity Test
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Science CorporationLead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled
Pixium Vision SALead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

PRIMA (Retinal Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT03392324 — N/A
Age-Related Macular Degeneration Research Study Groups: PRIMA
Age-Related Macular Degeneration Clinical Trial 2023: PRIMA Highlights & Side Effects. Trial Name: NCT03392324 — N/A
PRIMA (Retinal Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03392324 — N/A
~1 spots leftby Dec 2025
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