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

• ClinicalTrials.gov Identifier: NCT03333954
• Recruitment Status: Active, not recruiting
• First Posted: November 7, 2017
• Last Update Posted: March 10, 2021
• Sponsor: Pixium Vision SA
• Information provided by (Responsible Party): Pixium Vision SA

Tracking Information

• First Submitted Date: October 27, 2017
• First Posted Date: November 7, 2017
• Last Update Posted Date: March 10, 2021
• Actual Study Start Date: November 6, 2017
• Estimated Primary Completion Date: August 27, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2018)

• Elicitation of perception [ Time Frame: 6 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 6 weeks after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 3 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 12 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 18 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 24 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Elicitation of perception [ Time Frame: 36 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

Original Primary Outcome Measures (submitted: November 2, 2017)

• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 6 weeks after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 3 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 6 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 12 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 18 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 24 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.
• Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates [ Time Frame: 36 months after implantation ]
  The primary efficacy endpoint is the assessment of the device performance to demonstrate principal functionality of the PRIMA system. It is assessed by measuring the capability of the patient to perceive light at specific locations. To prove the functionality of the device, patients are tested with the device on and off.

Current Secondary Outcome Measures (submitted: March 8, 2021)

• Visual Acuity [ Time Frame: 18, 24 and 36 months after implantation if applicable ]
  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
• Letter Visual Acuity [ Time Frame: 48, 60 and 72 month after implantation ]
  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
• Quality of Live measured by IVI [ Time Frame: 48, 60 and 72 month after implantation ]
  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)

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration
• Official Title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration
• Brief 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Dry Age-related Macular Degeneration

Intervention

Device: PRIMA

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 Arms: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 2, 2017): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 27, 2024
• Estimated Primary Completion Date: August 27, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 informed consent

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 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03333954
• Other Study ID Numbers: CIP-PRIMA-FS
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pixium Vision SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Pixium Vision SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pixium Vision SA
• Verification Date: March 2021