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

May 27, 2026 updated by: Science Corporation

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Hôpital Pellegrin
      • Créteil, France, 94000
        • Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
      • Marseille, France, 13008
        • Centre Monticelli Paradis
      • Nantes, France, 44093
        • CHU de Nantes
      • Paris, France, 75019
        • Fondation Ophtalmologique A. de Rothschild
      • Paris, France, 75012
        • Hopital des Quinze Vingts
    • Lyon
      • Lyon, Lyon, France, 69004
        • Hôpital de la Croix-Rousse CHU de LYON
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
      • Bonn, Germany, 53127
        • Universitäts-Augenklinik Bonn
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik
      • Ludwigshafen am Rhein, Germany, 67063
        • Klinikum Ludwigshafen -Augenklinik
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
      • Munich, Germany, 80336
        • Augenklinik der Ludwig-Maximilian Universität München
      • Münster, Germany, 48149
        • Universitäts-Augenklinik Münster
      • Sulzbach, Germany, 66280
        • KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm
  • Italy
      • Roma, Italy, 00133
        • Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia
  • Netherlands
      • Rotterdam, Netherlands, 3011 BH
        • Rotterdam Eye Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Instituto de Microcirugía Ocular de Barcelona
  • United Kingdom
      • London, United Kingdom, 0207 566 2117
        • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRIMA Bionic Vision System
Device: PRIMA Bionic Vision System
Implantation of PRIMA, Vision training, follow up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with meaningful improvement of visual acuity
Time Frame: 12 months
Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months
12 months
Serious Adverse Events
Time Frame: 12 months
Number and severity of device and procedure related serious adverse events at 12 months follow-up
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Central visual perception
Time Frame: 12 months
Central visual perception with PRIMA at 12 months compared to central visual perception at baseline
12 months
Proportion of compliant implantations
Time Frame: 4 weeks after implantation
Number of subjects with PRIMA implant placed according protocol
4 weeks after implantation
Proportion of subjects with meaningful improvement of visual acuity
Time Frame: 6 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
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
6 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
Improvement of visual acuity
Time Frame: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
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
6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
Quality of life measured by IVI
Time Frame: 6 months, 12 months, 24 months, 36 months and at 72 months in study extension
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
6 months, 12 months, 24 months, 36 months and at 72 months in study extension
Adverse Events
Time Frame: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
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
6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
Change of natural visual acuity
Time Frame: 6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension
Change of natural visual acuity without the PRIMA Glasses
6 months, 12 months, 24 months, 36 months and 48 months, 60 months and 72 months in study extension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Science Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-PV-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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