PRIMA Retinal Prosthesis for Dry Age-Related Macular Degeneration

(PRIMA-FS-US Trial)

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

5 Participants Needed

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.

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 data supports the effectiveness of the PRIMA treatment for dry age-related macular degeneration?

Research shows that a visual prosthetic device for macular degeneration improved vision in 72% of patients in clinical trials, and a similar subretinal prosthesis in non-human primates showed promising results for restoring vision, suggesting potential effectiveness for the PRIMA treatment. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 2 3 4 9}

Research Team

Joseph Martel, MD

Principal Investigator

UPMC Pittsburgh

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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute Rabbit Eye Model for Testing Subretinal Prostheses. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Behavioural responses to a photovoltaic subretinal prosthesis implanted in non-human primates. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Electronic Retinal Prostheses. [2023]

4. England pubmed.ncbi.nlm.nih.gov

An update on visual prosthesis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Visual prosthetic device for bilateral end-stage macular degeneration. [2008]

6. Germany pubmed.ncbi.nlm.nih.gov

Characterization of a Polymer-Based, Fully Organic Prosthesis for Implantation into the Subretinal Space of the Rat. [2022]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A bioengineered retinal pigment epithelial monolayer for advanced, dry age-related macular degeneration. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Retinotopic Responses in the Visual Cortex Elicited by Epiretinal Electrical Stimulation in Normal and Retinal Degenerate Rats. [2022]