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

• ClinicalTrials.gov Identifier: NCT03392324
• Recruitment Status: Recruiting
• First Posted: January 5, 2018
• Last Update Posted: August 21, 2020
• Sponsor: Pixium Vision SA
• Collaborator: Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SA
• Information provided by (Responsible Party): Pixium Vision SA

Tracking Information

• First Submitted Date: December 29, 2017
• First Posted Date: January 5, 2018
• Last Update Posted Date: August 21, 2020
• Actual Study Start Date: April 26, 2018
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 26, 2019)

Near Visual Acuity [ Time Frame: 12 months after implantation ]

Near Visual acuity measured by FrACT

Original Primary Outcome Measures (submitted: December 29, 2017)

Elicitation of visual perception [ Time Frame: 12 months after implantation ]

Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field

Current Secondary Outcome Measures (submitted: November 26, 2019)

• Near Visual Acuity [ Time Frame: 3, 6, 9, 18, 24, and 36 months after implantation ]
  Near Visual acuity measured by FrACT
• Visual acuity [ Time Frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation ]
  Visual acuity measured by ETDRS
• Reading acuity test [ Time Frame: 6, 12, 24, 36 months after implantation ]
  Reading acuity measured by Radner Charts

Original Secondary Outcome Measures (submitted: December 29, 2017)

• Elicitation of visual perception [ Time Frame: 3, 6, 9, 18, 24, and 36 months after implantation ]
  Elicitation of visual perception by electrical stimulation of the PRIMA implant measured by Octopus Visual Field
• Visual acuity [ Time Frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation ]
  Visual acuity measured by ETDRS
• Near Visual Acuity [ Time Frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation ]
  Near Visual acuity measured by FrACT
• Reading acuity test [ Time Frame: 6, 12, 24, 36 months after implantation ]
  Reading acuity measured by Radner Charts

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

Descriptive Information

• Brief Title: PRIMA US-Feasibility Study in Atrophic Dry AMD
• Official Title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
• 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.
• 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
• 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

Implantation of PRIMA device

Study Arms

Experimental: PRIMA

Implantation of PRIMA device

Intervention: Device: PRIMA

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 29, 2017): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ralf Hornig, PhD; +33 17621 ext 4742; rhornig@pixium-vision.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03392324
• Other Study ID Numbers: CIP-PRIMA-FS-US
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Pixium Vision SA
• Study 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

• PRS Account: Pixium Vision SA
• Verification Date: August 2020