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PRIMA US-Feasibility Study in Atrophic Dry AMD (PRIMA-FS-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392324
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : March 17, 2023
Sponsor:
Collaborator:
Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA
Information provided by (Responsible Party):
Pixium Vision SA

Study Description
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Brief Summary:
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Device: PRIMA Not Applicable

Detailed Description:
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRIMA
Implantation of PRIMA device
 Device: PRIMA
Implantation of PRIMA device


Outcome Measures
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Primary Outcome Measures :
  1. Near Visual Acuity [ Time Frame: 12 months after implantation ]
    Near Visual acuity measured by FrACT


Secondary Outcome Measures :
  1. Near Visual Acuity [ Time Frame: 3, 6, 9, 18, 24, and 36 months after implantation ]
    Near Visual acuity measured by FrACT

  2. Visual Acuity [ Time Frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation ]
    Visual acuity measured by ETDRS

  3. Reading Acuity Test [ Time Frame: 6, 12, 24, 36 months after implantation ]
    Reading acuity measured by Radner Charts

  4. Quality of Life [ Time Frame: 12, 24, and 36 months after implantation ]
    The change in quality of life is measure by the Impact of Vision Impairment (IVI) Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is 60 years or older at the date of inclusion;
  • Has a confirmed diagnosis of atrophic dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters in the study eye;
  • Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS;
  • Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5 degrees) and maximum 20% perception in the remaining visual field covering the central 12 degrees (+/- 6 degrees);

  • Meets one of the following criteria in the non-study eye:

    • Visual acuity of 20/200 (logMAR 1.0) or worse and an atrophy size <8mm2
    • Visual acuity of 20/160 (logMAR 0.9) or worse and an atrophy size ≥8mm2 and ≤12.5 mm2
    • Visual acuity of 20/100 (logMAR 0.7) or worse and an atrophy size >12.5 mm2
  • Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
  • Understands and accepts the obligation to present for all schedule follow-up visits;
  • Patient signed informed consent.

Main Exclusion Criteria:

  • Has cataract in the study ;
  • Has an aphakic study eye;
  • Has no light perception in the study eye;
  • Has a history of choroidal neovascularization in either eye;
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye
  • Has an implanted telescope in one eye;
  • Has any disease or condition that prevents adequate examination of the study
  • 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
  • Has a history of epileptic seizure;
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
  • Presents with hypotony or hypertony in the study eye;
  • Has another active implanted device;
  • Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis;
  • Is an immune-suppressed subject;
  • Is 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 present study;
  • Has recurrent or chronic inflammations or infections;
  • 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;
  • Has head dimensions that are incompatible with the Visual Interface;
  • Has too high and unrealistic expectation;

Detailed patient criteria will be verified by the study doctor.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392324


Locations
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United States, California
Byers Eye Institute-Stanford University
Palo Alto, California, United States, 94303
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Pennsylvania
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Pixium Vision SA
Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA
Investigators
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Principal Investigator: Joseph Martel, MD UPMC Pittsburgh
More Information
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Additional Information:

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Responsible Party: Pixium Vision SA
ClinicalTrials.gov Identifier: NCT03392324    
Other Study ID Numbers: CIP-PRIMA-FS-US
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Pixium Vision SA:
atrophic macular degeneration
geographic atrophy
retina implant
retinal prosthesis
 visual prosthesis
macular degeneration
dry macular degeneration
AMD
Additional relevant MeSH terms:
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Macular Degeneration
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical