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Argus II Retinal Prosthesis System - Better Vision RP Study

Primary Purpose

Retinitis Pigmentosa

Status

Withdrawn

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Argus II Retinal Prosthesis

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults, age 25 years or older;
Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;
A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry;
Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;
Previous history of useful form vision;
Provided written, informed consent to participate in the study.

Exclusion Criteria:

Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, 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.);
Pre-disposition to eye rubbing;
Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
1. cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
2. psychiatric disease including diagnosed forms of depression;
3. does not speak a principal language associated with the region, and
4. 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;
Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
Conditions likely to limit life to less than 1 year from the time of inclusion.

Sites / Locations

Augenklinik Städtisches Klinikum Karlsruhe
University Medical Center Schleswig-Holstein, Department of Ophthalmology
RWTH University Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Argus II

Arm Description

Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects.

Outcomes

Primary Outcome Measures

Adverse events

The nature and number of adverse events in implanted subjects.

Visual field

The effect of the Argus II System on visual field size, as measured by Goldmann perimetry

Secondary Outcome Measures

Visual function

Effect of the Argus II System on visual function, as measured by a suite of visual tests

Quality of Life

Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)

Functional vision and quality of life

The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)

Full Information

NCT ID

NCT03418116

First Posted

January 25, 2018

Last Updated

June 21, 2019

Sponsor

Second Sight Medical Products

1. Study Identification

Unique Protocol Identification Number

NCT03418116

Brief Title

Argus II Retinal Prosthesis System - Better Vision RP Study

Official Title

Argus II Retinal Prosthesis System - Better Vision RP Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Company Decision

Study Start Date

November 1, 2018 (Anticipated)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Sight Medical Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.

Detailed Description

The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted. The majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light. Safety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this "better vision" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Argus II

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Argus II Retinal Prosthesis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adverse events

Description

The nature and number of adverse events in implanted subjects.

Time Frame

2 Years

Title

Visual field

Description

The effect of the Argus II System on visual field size, as measured by Goldmann perimetry

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

Visual function

Description

Effect of the Argus II System on visual function, as measured by a suite of visual tests

Time Frame

2 Years

Title

Quality of Life

Description

Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)

Time Frame

2 Years

Title

Functional vision and quality of life

Description

The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults, age 25 years or older; Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease; A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry; Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart; Previous history of useful form vision; Provided written, informed consent to participate in the study. Exclusion Criteria: Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, 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.); 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; Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery; Conditions likely to limit life to less than 1 year from the time of inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Walter, Prof Dr med

Organizational Affiliation

RWTH Aachen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Augenklinik Städtisches Klinikum Karlsruhe

City

Karlsruhe

State/Province

Baden-Wurttemberg

ZIP/Postal Code

76133

Country

Germany

Facility Name

University Medical Center Schleswig-Holstein, Department of Ophthalmology

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

RWTH University Eye Clinic

City

Aachen

ZIP/Postal Code

52074

Country

Germany

12. IPD Sharing Statement

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Argus II Retinal Prosthesis System - Better Vision RP Study

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