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Dry Age-related Macular DegenerationPRIMA FSNCT03333954

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

A study testing PRIMA Bionic Vision System in people with Dry Age-related Macular Degeneration, run by Science Corporation at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dry Age-related Macular Degeneration
What is being tested?
PRIMA Bionic Vision System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteFrance
Study dates
6 Nov 2017to 12 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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 informed consent

Who cannot join

  • 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;
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  • 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 informed consent, 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 metastasis;
  • Is an immune-suppressed subject (e.g., due to HIV 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 investigational 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Fondation Ophtalmologique A. De Rothschild/ Hopital des Quinze Vingts/

    Paris, 75019

Other trials in France

About this study

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.

Being tested
PRIMA Bionic Vision System
Keywords
atrophic macular degeneration, geographic atrophy, macular degeneration, dry macular degeneration, AMD, retina implant, retinal prosthesis, visual prosthesis
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRIMA Bionic Vision SystemDevice

    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

Study groups in NCT03333954
Study groupRoleWhat they receive
PRIMA Bionic Vision SystemExperimentalPRIMA Bionic Vision System
Receives: Device: PRIMA Bionic Vision System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Elicitation of perception

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

    Measured: 6 months after implantation

  2. Elicitation of perception

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

    Measured: 6 weeks after implantation

  3. Elicitation of perception

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

    Measured: 3 months after implantation

  4. Elicitation of perception

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

    Measured: 12 months after implantation

  5. Elicitation of perception

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

    Measured: 18 months after implantation

  6. Elicitation of perception

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

    Measured: 24 months after implantation

  7. Elicitation of perception

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

    Measured: 36 months after implantation

Secondary outcomes (3)

  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

    Measured: 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

    Measured: 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)

    Measured: 48, 60 and 72 month after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start6 Nov 2017
  3. Primary completion12 Dec 2024
  4. Study completion12 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03333954
Sponsor's protocol ID
CIP-PRIMA-FS
Acronym
PRIMA FS
Status last verified
Mar 2026
First submitted
27 Oct 2017
Last updated
2 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing PRIMA Bionic Vision System in people with Dry Age-related Macular Degeneration, run by Science Corporation at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elicitation of perception (time frame: 6 months after implantation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03333954, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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