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Argus® II Retinal Stimulation System Feasibility Protocol

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implant of Argus II Retinal Prosthesis
Sponsored by
Second Sight Medical Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, device, retinal implant, retinal prosthesis, RP, outer retinal degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes.
  • Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.
  • A history of former useful form vision in the worse-seeing eye.
  • Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old
  • Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site.
  • Must be willing and able to comply with the protocol testing and follow-up requirements.

Exclusion Criteria:

  • Optic Nerve disease

    • History of glaucoma
    • Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage
  • Diseases or conditions that effect retinal function including but not limited to:

    • Central retinal artery/vein occlusion (CRAO or CRVO)
    • End-stage diabetic retinopathy
    • Retinal detachment or history of retinal detachment
    • Trauma
    • Infectious or inflammatory retinal diseases
  • Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.
  • Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.
  • Diseases of the ocular surface including but not limited to keratitis sicca.
  • An ocular condition that predisposes the subject 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 neurological disease
    • Psychiatric Disease including diagnosed forms of depression
    • Does not speak a principal language associated with the region
    • Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
  • Pregnancy
  • Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head
  • Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly.
  • Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study
  • Any health concern that makes general anesthesia inadvisable.
  • Subject has unrealistic expectations of the implant.
  • Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications.
  • Conditions likely to limit life to less than 1 year from the time of screening.
  • Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus)
  • Axial eye length <21.5 mm or >26.0 mm in the implanted eye as measured by ultrasound (US only)

Sites / Locations

  • Doheny Eye Institute
  • University of California San Francisco
  • Johns Hopkins, Wilmer Eye Institute
  • Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute
  • University of Pennsylvania, Scheie Eye Institute
  • Wills Eye Hospital
  • Retina Foundation of the Southwest
  • Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12
  • Puerta de Hierro, Centro Medico, Centro de Retina
  • Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205
  • Moorfields Eye Hospital, Vitreoretinal Research Unit
  • Manchester Royal Eye Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Implant of Argus II Retinal Prosthesis

Arm Description

This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.

Outcomes

Primary Outcome Measures

Visual Acuity
Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.
Number of Participants With Adverse Events
Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation

Secondary Outcome Measures

Massof Activity Inventory
The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).
Quality of Life - Tasks for Daily Living
Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.
Orientation and Mobility
Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.
Visual Function
Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.
Stability of Implant - 5 Years Post Implant
Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.
Device Reliability
Number of participants with functional devices 10 years post implant

Full Information

First Posted
December 1, 2006
Last Updated
January 11, 2022
Sponsor
Second Sight Medical Products
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00407602
Brief Title
Argus® II Retinal Stimulation System Feasibility Protocol
Official Title
Argus® II Retinal Stimulation System Feasibility Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Sight Medical Products
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa. Post-Approval Phase of the Study: To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System
Detailed Description
During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
retinitis pigmentosa, device, retinal implant, retinal prosthesis, RP, outer retinal degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implant of Argus II Retinal Prosthesis
Arm Type
Other
Arm Description
This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.
Intervention Type
Device
Intervention Name(s)
Implant of Argus II Retinal Prosthesis
Intervention Description
epiretinal implantation of device
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.
Time Frame
10 years
Title
Number of Participants With Adverse Events
Description
Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Massof Activity Inventory
Description
The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).
Time Frame
3 years
Title
Quality of Life - Tasks for Daily Living
Description
Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.
Time Frame
3 years
Title
Orientation and Mobility
Description
Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.
Time Frame
5 years
Title
Visual Function
Description
Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.
Time Frame
10 years
Title
Stability of Implant - 5 Years Post Implant
Description
Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.
Time Frame
5 years
Title
Device Reliability
Description
Number of participants with functional devices 10 years post implant
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes. Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception. A history of former useful form vision in the worse-seeing eye. Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site. Must be willing and able to comply with the protocol testing and follow-up requirements. Exclusion Criteria: Optic Nerve disease History of glaucoma Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage Diseases or conditions that effect retinal function including but not limited to: Central retinal artery/vein occlusion (CRAO or CRVO) End-stage diabetic retinopathy Retinal detachment or history of retinal detachment Trauma Infectious or inflammatory retinal diseases Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant. Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions. Diseases of the ocular surface including but not limited to keratitis sicca. An ocular condition that predisposes the subject 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 neurological disease Psychiatric Disease including diagnosed forms of depression Does not speak a principal language associated with the region Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts. Pregnancy Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly. Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study Any health concern that makes general anesthesia inadvisable. Subject has unrealistic expectations of the implant. Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications. Conditions likely to limit life to less than 1 year from the time of screening. Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus) Axial eye length <21.5 mm or >26.0 mm in the implanted eye as measured by ultrasound (US only)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Ripley
Organizational Affiliation
Second Sight Medical Products
Official's Role
Study Director
Facility Information:
Facility Name
Doheny Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Johns Hopkins, Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Pennsylvania, Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12
City
Paris
Country
France
Facility Name
Puerta de Hierro, Centro Medico, Centro de Retina
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
51116
Country
Mexico
Facility Name
Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205
City
Geneva
Country
Switzerland
Facility Name
Moorfields Eye Hospital, Vitreoretinal Research Unit
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Manchester Royal Eye Hospital
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22260934
Citation
Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.
Results Reference
background
PubMed Identifier
22244176
Citation
Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.
Results Reference
result
PubMed Identifier
22661464
Citation
Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.
Results Reference
result
PubMed Identifier
20881025
Citation
Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.
Results Reference
result
PubMed Identifier
34706764
Citation
Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.
Results Reference
derived
PubMed Identifier
25414187
Citation
Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.
Results Reference
derived
PubMed Identifier
24049718
Citation
Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.
Results Reference
derived
PubMed Identifier
24013578
Citation
de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.
Results Reference
derived
PubMed Identifier
23611993
Citation
Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.
Results Reference
derived
PubMed Identifier
23544203
Citation
Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.
Results Reference
derived
PubMed Identifier
23500412
Citation
Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.
Results Reference
derived
PubMed Identifier
22761263
Citation
Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.
Results Reference
derived
PubMed Identifier
22447863
Citation
Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.
Results Reference
derived

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Argus® II Retinal Stimulation System Feasibility Protocol

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