ClinicalTrials.gg
CompletedNCT03392324PRIMA-FS-USUpdated Aug 17, 2026

PRIMA US-Feasibility Study in Atrophic Dry AMD

An interventional study of PRIMA in Dry Age-related Macular Degeneration, sponsored by Science Corporation. Completed at 3 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 45 under way, 5 of them phase 3. Geographic Atrophy · United States.

Enrollment
104th of 107
5 · median 98
Started
2018
with 7 others
No phase
11 of 131
4 open now
Registered
51st of 131
by date

Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 104th largest by enrollment of the 107 interventional ones that give a count, is one of 8 that started in 2018, is one of 11 with no phase, and was the 51st registered.

Geographic Atrophy

188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.

Browse Geographic Atrophy studies →

Open to participants now

35 of the 131 studies in Geographic Atrophy with a site in United States are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.

03

Conditions studied

  • Dry Age-related Macular Degeneration

Keywords

  • atrophic macular degeneration
  • geographic atrophy
  • retina implant
  • retinal prosthesis
  • visual prosthesis
  • macular degeneration
  • dry macular degeneration
  • AMD
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Is 60 years or older at the date of inclusion;
  • Has a confirmed diagnosis of atrophic dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters in the study eye;
  • Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS;
  • Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5 degrees) and maximum 20% perception in the remaining visual field covering the central 12 degrees (+/- 6 degrees);
  • 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
  • Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
  • Understands and accepts the obligation to present for all schedule follow-up visits;
  • Patient signed .

Main Exclusion Criteria:

  • Has cataract in the study ;
  • Has an aphakic study eye;
  • Has no light perception in the study eye;
  • Has a history of choroidal neovascularization in either eye;
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye
  • Has an implanted telescope in one eye;
  • Has any disease or condition that prevents adequate examination of the study
  • Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye
  • Suffers from nystagmus or other ocular motility disorders;
  • Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols
  • Has a history of epileptic seizure;
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
  • Presents with hypotony or hypertony in the study eye;
  • Has another active implanted device;
  • Has active cancer or a history of intraocular, optic nerve or brain cancer and ;
  • Is an immune-suppressed subject;
  • Is carrier of multi-resistant microorganisms;
  • Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery;
  • Is participating in another drug or device study that may interfere with the present study;
  • Has recurrent or chronic inflammations or infections;
  • Has a severe psychological disorder;
  • Does not have the mental capacity to legally sign the informed consent;
  • Has severe renal, cardiac, hepatic, etc. organ diseases;
  • Has head dimensions that are incompatible with the Visual Interface;
  • Has too high and unrealistic expectation;

Detailed patient criteria will be verified by the study doctor.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    PRIMA

    Implantation of PRIMA device

    Device: PRIMA

Interventions

  • DevicePRIMA

    Implantation of PRIMA device

06

What researchers measure

Primary outcomes

  1. Near Visual Acuity

    Near Visual acuity measured by FrACT

    Time frame: 12 months after implantation

Secondary outcomes

  1. Near Visual Acuity

    Near Visual acuity measured by FrACT

    Time frame: 3, 6, 9, 18, 24, and 36 months after implantation

  2. Visual Acuity

    Visual acuity measured by ETDRS

    Time frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation

  3. Reading Acuity Test

    Reading acuity measured by Radner Charts

    Time frame: 6, 12, 24, 36 months after implantation

  4. Quality of Life Questionnaire

    The change in quality of life is measure by the Impact of Vision Impairment (IVI) Questionnaire

    Time frame: 12, 24, and 36 months after implantation

07

Study locations

3 sites
  • Byers Eye Institute-Stanford University
    Palo Alto, California 94303, United States
  • Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
  • UPMC Eye Center
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in May 2026, 96 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2017
First posted
Jan 5, 2018
StartActual
Apr 26, 2018
Primary completionActual
May 20, 2026
CompletionActual
May 20, 2026
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03392324
Lead sponsor
Science Corporation
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Apr 26, 2018
Primary completion
May 20, 2026
Completion
May 20, 2026
Last update
Aug 17, 2026

Study contacts

Joseph Martel, MD
principal investigator · UPMC Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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