PRIMA Retinal Prosthesis for Dry Age-Related Macular Degeneration
(PRIMA-FS-US Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJoseph Martel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Science Corporation

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients)

Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS

I have signed the informed consent form.

+5 more

Exclusion 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.

+22 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: PRIMAExperimental Treatment1 Intervention

Implantation of PRIMA device