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

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: Active, not recruiting
• Conditions: Geographic Atrophy
• Intervention / Treatment: Device: PRIMA Bionic Vision System

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Hornig, PhD; Phone Number: +33176214742; Email: clinical-trial@pixium-vision.com

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin
  • Créteil, France, 94000
    • Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
  • Lyon, France, 69004
    • Hôpital de la Croix-Rousse CHU de LYON
  • 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
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
  • Bonn, Germany, 53127
    • Universitats-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/Saar, 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
  • Schiedamse Vest 160
    • Rotterdam, Schiedamse Vest 160, 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

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	12 months
Serious Adverse Events	Number and severity of device and procedure related serious adverse events at 12 months follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 24 and 36 months compared to baseline	6, 24, 36 months
Improvement of visual acuity	Mean improvement of visual acuity at 6, 12, 24 and 36 months compared to baseline	6, 12, 24, 36 months
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, 12, 24 and 36 months	6, 12, 24, 36 months
Central visual perception	Central visual perception with PRIMA at 12 months compared to central visual perception at baseline	12 months
Adverse Events	Number and severity of procedure and device related adverse events at 6, 12, 24 and 36 months follow-up	6, 12, 24, 36 months
Change of natural visual acuity	Change of natural visual acuity without the PRIMA Glasses	6, 12, 24, 36 months
Proportion of compliant implantations	Number of subjects with PRIMA implant placed according protocol	4 weeks after implantation

Collaborators and Investigators

• Sponsor: Pixium Vision SA

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pixium Vision

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 24, 2020
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): February 1, 2026

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 21, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Geographic Atrophy
• Other Study ID 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