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Geographic AtrophyPRIMAveraNCT04676854

Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD

A study testing PRIMA Bionic Vision System in people with Geographic Atrophy, run by Science Corporation at 21 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
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
38 participants
Where
21 sitesin 6 countries
Study dates
24 Nov 2020to Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 inclusion;
  • Has a confirmed diagnosis of geographic atrophy due to AMD in both eyes;
  • The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test;
  • Has an atrophic patch in the study eye including the fovea of at least the implant size (>4.5 mm2 and >2.4 mm in minimum diameter);
  • Understands the constraints of the study and accepts to present for all scheduled follow-up visits;
  • Patient signed informed consent

Who cannot join

  • Has cataract in the study eye (with LOCS III scale NO, NC, C or P>1); (these patients will be asked to have cataract surgery performed prior to enrollment; all other patients will get IOL replacement during the PRIMA implantation);
  • Underwent intra ocular lens implantation in the study eye within the last month ;
  • Has a highly myopic study eye (>26 mm AP);
  • Has a highly hyperopic study eye (<20 mm AP);
  • Has no light perception in either eye;
  • Has a history of documented choroidal neovascularization in either eye;
Show all 37Show fewer
  • Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye;
  • Has an implanted telescope in one eye;
  • Has a black IOL in the study eye;
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, Proliferative Diabetic Retinopathy (PDR), diabetic macular edema (DME), severe Non-Proliferative Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, etc.) ;
  • Has any disease or condition that prevents adequate examination (including OCT) of the study eye including, but not limited to media opacities that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant;
  • 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 (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc.);
  • Has epileptic seizures;
  • Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium);
  • Has a known allergy to anesthetic drugs;
  • Presents with hypotonia in the study eye (<8 mmHg);
  • Presents with hypertonia in the study eye (>23 mmHg with treatment);
  • 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 a known carrier of multi-resistant microorganisms;
  • 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 PRIMAvera study;
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
  • Has significant recurrent or chronic inflammations or infections. Specifically, patients with the following disorders are excluded:
  • 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;
  • Does not have the mental capacity to legally sign the informed consent;
  • Has severe renal, cardiac, hepatic, etc. organ diseases (ASA IV or worse);
  • Has head dimensions that are incompatible with the PRIMA Glasses;
  • Has a refraction of study eye higher than + 4 dpt or lower than - 4 dpt for patients with IOL (there is no refraction criteria for phakic patients, since they get an IOL during PRIMA implantation);
  • Has too high and/or unrealistic expectations (e.g., believes that a benefit is guaranteed or expects normal vision after surgery).
  • The following additional exclusion criteria are applicable for French subjects:
  • Is a protected person per French law (e.g. is under guardianship, person deprived of their liberty);
  • Is not affiliated to a mandatory social security program (health insurance).

Trial locations and contacts

21 sites in 6 countries.

21 sites in 6 countries

Germany10 sites

  • Universitätsklinikum Aachen, Klinik fuer Augenheilkunde

    Aachen, 52074

  • Universitäts-Augenklinik Bonn

    Bonn, 53127

  • Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik

    Hamburg, 20251

  • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

    Lübeck, 23538

  • Klinikum Ludwigshafen -Augenklinik

    Ludwigshafen am Rhein, 67063

  • Augenklinik der Ludwig-Maximilian Universität München

    Munich, 80336

  • Universitäts-Augenklinik Münster

    Münster, 48149

  • KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach

    Sulzbach, 66280

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

France7 sites

  • Hôpital Pellegrin

    Bordeaux, 33000

  • Centre hospitalier intercommunal de Créteil - Service Ophtalmologie

    Créteil, 94000

  • Hôpital de la Croix-Rousse CHU de LYON

    Lyon, Lyon, 69004

  • Centre Monticelli Paradis

    Marseille, 13008

  • CHU de Nantes

    Nantes, 44093

  • Hopital des Quinze Vingts

    Paris, 75012

  • Fondation Ophtalmologique A. De Rothschild

    Paris, 75019

Other trials in France

Italy1 site

  • Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia

    Roma, 00133

Other trials in Italy

Netherlands1 site

  • Rotterdam Eye Hospital

    Rotterdam, 3011 BH

Other trials in Netherlands

Spain1 site

  • Instituto de Microcirugía Ocular de Barcelona

    Barcelona, 08035

Other trials in Spain

United Kingdom1 site

  • Moorfields Eye Hospital NHS Foundation Trust

    London, 0207 566 2117

Other trials in United Kingdom

About this study

Official title: Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration

The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).

Being tested
PRIMA Bionic Vision System
Medical subject headings
Geographic Atrophy

What participants receive

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

  • PRIMA Bionic Vision SystemDevice

    Implantation of PRIMA, Vision training, follow up

Study groups in NCT04676854
Study groupRoleWhat they receive
PRIMA Bionic Vision SystemExperimentalNot described
Receives: Device: PRIMA Bionic Vision System

What is being measured

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

  1. Proportion of subjects with meaningful improvement of visual acuity

    Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months

    Measured: 12 months

  2. Serious Adverse Events

    Number and severity of device and procedure related serious adverse events at 12 months follow-up

    Measured: 12 months

Secondary outcomes (7)

  1. Proportion of subjects with meaningful improvement of visual acuity

    Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more at 6 months, 24 months and 36 months compared to baseline and subjects in study extension at 48 months, 60 months and 72 months compared to baseline

    Measured: 6 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension

  2. Improvement of visual acuity

    Mean improvement of visual acuity at 6 months, 12 months, 24 months and 36 months compared to baseline and subjects in study extension at 48 months, 60 months and 72 months compared to baseline

    Measured: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension

  3. Quality of life 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) at 6 months, 12 months, 24 months and 36 months and subjects in study extension at 72 months

    Measured: 6 months, 12 months, 24 months, 36 months and at 72 months in study extension

  4. Central visual perception

    Central visual perception with PRIMA at 12 months compared to central visual perception at baseline

    Measured: 12 months

  5. Adverse Events

    Number and severity of procedure and device related adverse events at 6 months, 12 months, 24 months and 36 months follow-up and at 48 months, 60 months and 72 months in study extension follow-up

    Measured: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension

  6. Change of natural visual acuity

    Change of natural visual acuity without the PRIMA Glasses

    Measured: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension

  7. Proportion of compliant implantations

    Number of subjects with PRIMA implant placed according protocol

    Measured: 4 weeks 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 posted21 Dec 2020
  2. Study start24 Nov 2020
  3. Primary completion1 Feb 2024
  4. Study completionMar 2029 (estimated)

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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676854
Sponsor's protocol ID
CIP-PV-M
Acronym
PRIMAvera
Status last verified
May 2026
First submitted
16 Dec 2020
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holz FG, Le Mer Y, Muqit MMK, Hattenbach LO, Cusumano A, Grisanti S, Kodjikian L, Pileri MA, Matonti F, Souied E, Stanzel BV, Szurman P, Weber M, Bartz-Schmidt KU, Eter N, Delyfer MN, Girmens JF, van Overdam KA, Wolf A, Hornig R, Corazzol M, Brodie F, Olmos de Koo L, Palanker D, Sahel JA. Subretinal Photovoltaic Implant to Restore Vision in Geographic Atrophy Due to AMD. N Engl J Med. 2026 Jan 15;394(3):232-242. doi: 10.1056/NEJMoa2501396. Epub 2025 Oct 20.

    PubMed 41124203

Questions about this trial

What is this clinical trial studying?

A study testing PRIMA Bionic Vision System in people with Geographic Atrophy, run by Science Corporation at 21 sites in 6 countries.

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 6 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, France, Italy, Netherlands, Spain and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of subjects with meaningful improvement of visual acuity (time frame: 12 months). The study lists 2 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 NCT04676854, which also lists 1 linked publication.

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 1 Jun 2026.

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