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

NCT03333954 | Completed

• 1 other identifier: CIP-PRIMA-FS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Age-related Macular Degeneration

Keywords

atrophic macular degeneration; geographic atrophy; macular degeneration; dry macular degeneration; AMD; retina implant; retinal prosthesis; visual prosthesis

Outcome Measures

Primary Outcomes (7)

• Elicitation of perception

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

  6 months after implantation

• Elicitation of perception

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

  6 weeks after implantation

• Elicitation of perception

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

  3 months after implantation

• Elicitation of perception

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

  12 months after implantation

• Elicitation of perception

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

  18 months after implantation

• Elicitation of perception

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

  24 months after implantation

• Elicitation of perception

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

  36 months after implantation

Secondary Outcomes (3)

• Visual Acuity

  18, 24 and 36 months after implantation if applicable

• Letter Visual Acuity

  48, 60 and 72 month after implantation

• Quality of Live measured by IVI

  48, 60 and 72 month after implantation

Study Arms (1)

PRIMA Bionic Vision System

EXPERIMENTAL

PRIMA Bionic Vision System

Device: PRIMA Bionic Vision System

Interventions

PRIMA Bionic Vision System DEVICE

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

PRIMA Bionic Vision System

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (1)

Fondation Ophtalmologique A. De Rothschild/ Hopital des Quinze Vingts/

Paris, 75019, France

Location

Related Publications (5)

• 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.

  PMID: 35082313 RESULT

• Muqit MMK, Mer YL, Holz FG, Sahel JA. Long-term observations of macular thickness after subretinal implantation of a photovoltaic prosthesis in patients with atrophic age-related macular degeneration. J Neural Eng. 2022 Oct 14;19(5):10.1088/1741-2552/ac9645. doi: 10.1088/1741-2552/ac9645.

  PMID: 36174540 RESULT

• 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.

  PMID: 32249038 RESULT

• Muqit MMK, Le Mer Y, Olmos de Koo L, Holz FG, Sahel JA, Palanker D. Prosthetic Visual Acuity with the PRIMA Subretinal Microchip in Patients with Atrophic Age-Related Macular Degeneration at 4 Years Follow-up. Ophthalmol Sci. 2024 Mar 7;4(5):100510. doi: 10.1016/j.xops.2024.100510. eCollection 2024 Sep-Oct.

  PMID: 38881600 RESULT

• Muqit M, Mer YL, de Koo LO, Holz FG, Sahel JA, Palanker D. Prosthetic Visual Acuity with the PRIMA System in Patients with Atrophic Age-related Macular Degeneration at 4 years follow-up. medRxiv [Preprint]. 2023 Nov 13:2023.11.12.23298227. doi: 10.1101/2023.11.12.23298227.

  PMID: 38014146 DERIVED

Related Links

• Science Corporation

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 7, 2017
• Study Start: November 6, 2017
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)