PRIMA US-Feasibility Study in Atrophic Dry AMD

NCT03392324 | Active Not Recruiting FDA Device

• 1 other identifier: CIP-PRIMA-FS-US
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Dry Age-related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Near Visual Acuity

  Near Visual acuity measured by FrACT

  12 months after implantation

Secondary Outcomes (4)

• Near Visual Acuity

  3, 6, 9, 18, 24, and 36 months after implantation

• Visual Acuity

  3, 6, 9, 12, 18, 24 and 36 months after implantation

• Reading Acuity Test

  6, 12, 24, 36 months after implantation

• Quality of Life

  12, 24, and 36 months after implantation

Study Arms (1)

PRIMA

EXPERIMENTAL

Implantation of PRIMA device

Device: PRIMA

Interventions

PRIMA DEVICE

Implantation of PRIMA device

PRIMA

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (3)

Byers Eye Institute-Stanford University

Palo Alto, California, 94303, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Science corporation

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Joseph Martel, MD

  UPMC Pittsburgh

  PRINCIPAL INVESTIGATOR

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: December 29, 2017
• First Posted: January 5, 2018
• Study Start: April 26, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (3)