Post-Market Study of the Argus® II Retinal Prosthesis System - France

NCT02303288 | Completed DMC

• 1 other identifier: PM-03-01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (2)

• Functional Vision - FLORA

  The impact of the Argus II on subjects' lives (in terms of functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA)

  2 Years

• Adverse events

  Incidence of procedure- and device-related adverse events

  2 Years

Secondary Outcomes (4)

• Patient Satisfaction and ease of use of the System

  2 years

• Visual Function

  2 years

• Functional Vision

  2 years

• Explantation rate

  2 years

Interventions

Argus II Retinal Prosthesis System DEVICE

The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with retinitis pigmentosa who have bare light perception or worse in both eyes

You may qualify if:

• Are adults, age 25 years or older;
• Have retinitis pigmentosa with visual acuity of bare light perception or worse in both eyes;
• Have previous history of useful form vision;
• If the subject has no residual light perception, the retina must be able to respond to electrical stimulation;
• The subject is willing to provide written, informed consent to participate in the study.

You may not qualify if:

• Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.);
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length \<20.5 mm or \> 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
• Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity);
• Pre-disposition to eye rubbing;
• Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
• cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
• psychiatric disease including diagnosed forms of depression;
• does not speak a principal language associated with the region, and
• deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;
• Pregnant or wish to become pregnant during the course of the study;
• Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
• At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).
• Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.);
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length \<20.5 mm or \> 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
• Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity);

Sponsors & Collaborators

• Second Sight Medical Products: lead

Study Sites (3)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75571, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pierre-Olivier Barale, MD

  CHNO des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 27, 2014
• Study Start: November 20, 2014
• Primary Completion: March 20, 2018
• Study Completion: November 20, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

FR (3)