ClinicalTrials.gg
CompletedNCT03333954PRIMA FSUpdated Apr 2, 2026

Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration

An interventional study of PRIMA Bionic Vision System in Dry Age-related Macular Degeneration, sponsored by Science Corporation. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

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 · 2026-11-12

Among 30 studies in Geographic Atrophy with a site in France — 6 open to participants now, 10 under way, 3 of them phase 3. Geographic Atrophy · France.

Enrollment
25th of 25
5 · median 310
Started
2017
the only one that year
No phase
3 of 30
none open now
Registered
7th of 30
by date
Lead sponsor
2 of 30
Science Corporation

Among the 30 studies in Geographic Atrophy with a site in France, this one is the 25th largest by enrollment of the 25 interventional ones that give a count, is the only one that started in 2017, is one of 3 with no phase, and was the 7th 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

6 of the 30 studies in Geographic Atrophy with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

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

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.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Geographic Atrophy with a site in France, or all of them as a file.
02

Study summary

In this study, the principle functionality of the device will be tested in humans for the first time. The study will evaluate the extent to which patients with atrophic dry age related macular degeneration (AMD) have evoked light perception using the implant.

Read the detailed description

In this study subjects are provided with a PRIMA sub-retinal implant in one eye. A camera integrated in the external components of the implant captures visual information of the environment, this information is processed by a pocket processor and then transmitted via projected IR light onto the implant. The implant received the projected IR light and stimulates the nerve cells of the retina. Interim analysis will be performed at 6 months after implantation.

03

Conditions studied

  • Dry Age-related Macular Degeneration

Keywords

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

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Is 60 years or older at the date of enrolment;
  • Has a confirmed diagnosis of advanced dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters;
  • Has best corrected visual acuity of the study eye of logMAR 1.3 (20/400) or worse measured by ETDRS;
  • Has no foveal perception measured by micro-perimetry in the study eye (≤ 4 dB on Opko scale or equivalent) ;
  • Has a study eye that is able to perceive light;
  • Has useful vision on the non-study eye;
  • Has a refraction of study eye between -3 and + 4 (limits included) for patient with IOL (there is no refraction criteria for patients with natural lens);
  • Understands and accepts the obligation to present for all schedule follow-up visits.
  • Patient signed

Exclusion criteria

Exclusion Criteria:

  • Has cataracts that may influence the visual function of the study eye;
  • Has an aphakic study eye
  • Had cataract surgery in the last 1 month;
  • Active sub-macular choroidal neovascularization in the study eye;
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, myopic chorio-retinal atrophy etc.);
  • Has an implanted telescope in one eye;
  • Has any disease or condition that prevents adequate examination of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant;
  • Has an endothelia cell count of less than 1000 cells/mm² in the study eye;
  • Suffers from nystagmus;
  • Has any disease or condition that precludes the understanding or communication of the , study requirements or test protocols (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc);
  • Has a history of epileptic seizure;
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
  • Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium);
  • Presents with hypotony in the study eye;
  • Presents with hypertony in the study eye;
  • Has another active implanted device (e.g. cochlear implant, pacemaker) that may interfere with the device function, or diagnoses requiring such an active implant;
  • Has active cancer or a history of intraocular, optic nerve or brain cancer and ;
  • Is an immune-suppressed subject (e.g., due to positive diagnosis, etc.);
  • Is carrier of multi-resistant germs;
  • 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;
  • Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically, patients with the following disorders are excluded:

    • Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease);
    • Active inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion);
  • Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial. In any doubts of the subjects psychological status a clinical psychologist, psychologist or the community doctor/general practitioner should be involved. The patient must have the legal capacity to sign the informed consent;
  • Has severe renal, cardiac, hepatic etc. organ diseases;
  • Has head dimension that are incompatible with the Visual Interface.
  • Has too high and unrealistic expectation (e.g., believes that a benefit is guaranteed or expect normal vision after surgery)
Terms in these criteria, in plain language(4)

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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 Bionic Vision System

    PRIMA Bionic Vision System

    Device: PRIMA Bionic Vision System

Interventions

  • DevicePRIMA Bionic Vision System

    The PRIMA Bionic Vision System is a device for treatment of patients who have lost their sight through outer retinal degenerative conditions of the eye such as atrophic dry age related macular degeneration. The PRIMA System is designed to provide partial restoration of the patient's visual function through electrical stimulation of the retinal neurons by a sub-retinally implanted stimulator that replace part of the degenerate photoreceptors

06

What researchers measure

Primary outcomes

  1. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 6 months after implantation

  2. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 6 weeks after implantation

  3. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 3 months after implantation

  4. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 12 months after implantation

  5. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 18 months after implantation

  6. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 24 months after implantation

  7. Elicitation of perception

    Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

    Time frame: 36 months after implantation

Secondary outcomes

  1. Visual Acuity

    Visual acuity is a measure of the ability of the visual system to distinguish shapes and details of objects at a given distance. This study use the Landolt Ring to measure visual acuity

    Time frame: 18, 24 and 36 months after implantation if applicable

  2. Letter Visual Acuity

    Visual acuity is a measure of the ability of the visual system to distinguish shapes and details of objects at a given distance. This endpoint use the ETDRS charts to measure visual acuity

    Time frame: 48, 60 and 72 month after implantation

  3. Quality of Live measured by IVI

    IVI-Impact of Vision Impairment questionnaire (quality of life based on patient reported outcome of functional vision, participation in vision-related daily living activities and emotional well-being)

    Time frame: 48, 60 and 72 month after implantation

07

Study locations

1 site
  • Fondation Ophtalmologique A. De Rothschild/ Hopital des Quinze Vingts/
    Paris, 75019, France
08

References and documents

Publications

  • Palanker D, Le Mer Y, Mohand-Said S, Sahel JA. Simultaneous perception of prosthetic and natural vision in AMD patients. Nat Commun. 2022 Jan 26;13(1):513. doi: 10.1038/s41467-022-28125-x. PubMed 35082313 ↗
  • Muqit MMK, Mer YL, Holz FG, Sahel JA. Long-term observations of macular thickness after subretinal implantation of a photovoltaic prosthesis in patients with atrophic age-related macular degeneration. J Neural Eng. 2022 Oct 14;19(5):10.1088/1741-2552/ac9645. doi: 10.1088/1741-2552/ac9645. PubMed 36174540 ↗
  • Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25. PubMed 32249038 ↗
  • Muqit MMK, Le Mer Y, Olmos de Koo L, Holz FG, Sahel JA, Palanker D. Prosthetic Visual Acuity with the PRIMA Subretinal Microchip in Patients with Atrophic Age-Related Macular Degeneration at 4 Years Follow-up. Ophthalmol Sci. 2024 Mar 7;4(5):100510. doi: 10.1016/j.xops.2024.100510. eCollection 2024 Sep-Oct. PubMed 38881600 ↗
  • Muqit M, Mer YL, de Koo LO, Holz FG, Sahel JA, Palanker D. Prosthetic Visual Acuity with the PRIMA System in Patients with Atrophic Age-related Macular Degeneration at 4 years follow-up. medRxiv [Preprint]. 2023 Nov 13:2023.11.12.23298227. doi: 10.1101/2023.11.12.23298227. PubMed 38014146 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Dec 2024, 85 months.

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

Registered
Oct 27, 2017
First posted
Nov 7, 2017
StartActual
Nov 6, 2017
Primary completionActual
Dec 12, 2024
CompletionActual
Dec 12, 2024
Last update
Apr 2, 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 Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03333954
Lead sponsor
Science Corporation
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Nov 6, 2017
Primary completion
Dec 12, 2024
Completion
Dec 12, 2024
Last update
Apr 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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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