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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Age-related Macular Degeneration
• Intervention / Treatment: Device: PRIMA

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Hornig, PhD; Phone Number: 4742 +33 17621; Email: rhornig@pixium-vision.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute-Stanford University
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center

Participation Criteria

Eligibility Criteria

• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRIMA; Implantation of PRIMA device	Device: PRIMA; Implantation of PRIMA device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity	Near Visual acuity measured by FrACT	12 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity	Near Visual acuity measured by FrACT	3, 6, 9, 18, 24, and 36 months after implantation
Visual Acuity	Visual acuity measured by ETDRS	3, 6, 9, 12, 18, 24 and 36 months after implantation
Reading Acuity Test	Reading acuity measured by Radner Charts	6, 12, 24, 36 months after implantation
Quality of Life	The change in quality of life is measure by the Impact of Vision Impairment (IVI) Questionnaire	12, 24, and 36 months after implantation

Collaborators and Investigators

• Sponsor: Pixium Vision SA
• Collaborators: Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA
• Investigators: Principal Investigator: Joseph Martel, MD, UPMC Pittsburgh

Publications and helpful links

Helpful Links

• Pixium Vision

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: macular degeneration; AMD; retina implant; geographic atrophy; dry macular degeneration; atrophic macular degeneration; retinal prosthesis; visual prosthesis
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Atrophy
• Other Study ID Numbers: CIP-PRIMA-FS-US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes