PRIMA Retinal Prosthesis for Dry Age-Related Macular Degeneration

(PRIMA-FS-US Trial)

Not currently recruiting at 2 trial locations

Overseen By Ralf Hornig, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Science Corporation

Must not be taking: Anticoagulants

Disqualifiers: Cataract, Nystagmus, Epilepsy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called PRIMA, designed to assist individuals with a severe form of dry age-related macular degeneration, a condition affecting vision. The trial aims to determine the device's safety and effectiveness for those with significant vision impairment due to this condition. Participants will undergo implantation of the PRIMA device and must have a diagnosis of this type of macular degeneration with major vision loss in the study eye. They must also attend all follow-up visits and meet specific vision and eye health criteria. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatments for vision impairment.

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.

What prior data suggests that the PRIMA retinal prosthesis is safe for treating dry age-related macular degeneration?

Research has shown that the PRIMA retinal prosthesis is generally well-tolerated by patients. In studies involving individuals with age-related macular degeneration (AMD), no reports indicated that the device reduced natural vision. Participants received the PRIMA device implant without major issues. Serious side effects were uncommon, suggesting the device's safety. This evidence indicates it could be a promising option for those considering this treatment to restore vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PRIMA retinal prosthesis is unique because it directly targets vision loss in dry age-related macular degeneration (AMD) by implanting a tiny, wireless device onto the retina. Unlike current treatments, which mainly focus on slowing disease progression or managing symptoms with vitamins and lifestyle changes, PRIMA aims to restore some degree of vision by converting light into electrical signals that stimulate retinal cells. Researchers are excited about PRIMA because it offers a groundbreaking approach to potentially improving vision, rather than just preserving it.

What evidence suggests that the PRIMA retinal prosthesis is effective for dry age-related macular degeneration?

Research has shown that the PRIMA retinal implant, which participants in this trial will receive, can help people with dry age-related macular degeneration (AMD) see better. In earlier studies, patients with this condition read more easily after receiving the PRIMA implant. The implant functions like a tiny camera in the eye to help restore some lost vision. Studies have found that the implant is generally safe and does not cause major side effects. Early results also suggest that it improves visual clarity without affecting any remaining natural vision. ^{1 2 3 6 7}

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

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Treatment

Implantation of the PRIMA device and initial setup with the visual processing system

1 month

Monitoring and Adjustment

Participants undergo regular monitoring and adjustments to the device settings

6 months

Monthly visits (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness of the device

36 months

Visits at 3, 6, 9, 12, 18, 24, and 36 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PRIMA

Trial Overview 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.

How Is the Trial Designed?

Group I: PRIMA Experimental Treatment 1 Intervention

Implantation of PRIMA device

Who Is Running the Clinical Trial?

Science Corporation

Lead Sponsor

Trials

5

Recruited

80+

Pixium Vision SA

Lead Sponsor

Trials

5

Recruited

80+

Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA

Collaborator

Trials

1

Recruited

5+

Published Research Related to This Trial

Two phase I/II studies involving 18 patients with advanced macular degeneration showed that implanting human embryonic stem cell-derived retinal pigment epithelium (hESC-RPE) is safe and may improve visual acuity in over half of the treated patients.

No significant adverse events related to the cell therapy were observed, aside from one case of postoperative infection, suggesting a favorable safety profile for future studies and potential treatments for other retinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subretinal Transplantation of Embryonic Stem Cell-Derived Retinal Pigment Epithelium for the Treatment of Macular Degeneration: An Assessment at 4 Years. Schwartz, SD., Tan, G., Hosseini, H., et al.[2022]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2501396

Subretinal Photovoltaic Implant to Restore Vision in ... Geographic atrophy due to age-related macular degeneration (AMD) is the leading cause of irreversible blindness and affects more than 5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7618305/

Vision Restoration with the PRIMA System in Geographic ... Outcomes of Pars Plana Vitrectomy for Epiretinal Membrane in Eyes With Coexisting Dry Age-related Macular Degeneration. Ophthalmol Retina.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666914524000460

Prosthetic Visual Acuity with the PRIMA Subretinal ... Subretinal implantation of PRIMA in subjects with GA experiencing profound vision loss due to AMD is feasible and well tolerated, with no reduction of natural ...

4. macularsociety.org macularsociety.org/about/media/news/2025/october/revolutionary-implant-allows-patients-with-dry-amd-to-read-again/

Revolutionary implant allows patients with dry AMD to read ... A revolutionary new implant has restored some vision to patients with dry age-related macular degeneration (AMD), enabling them to read ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680875/

Prosthetic Visual Acuity with the PRIMA System in Patients ... Subretinal implantation of PRIMA in subjects with GA suffering from profound vision loss due to AMD is feasible and well tolerated, with no reduction of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03392324

PRIMA US-Feasibility Study in Atrophic Dry AMD 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 ...

7. science.xyz science.xyz/technologies/prima/

PRIMA Visual Prosthesis ... dry age-related macular degeneration (GA) (NCT04676854). The study is evaluating the safety and efficacy of the PRIMA implant for patients with AMD. Based ...